FDA Releases Draft Guidance on “Artificial Pancreas” to Fight Diabetes

June 21, 2011

FDA diabetes artificial pancreas

FDA Guidance for "Artificial Pancreas"

FDA released a draft guidace document for development of an “artificial pancreas,” a highly anticipated step in the fight against diabetes. At one time the onset of type 1 diabetes, where the body stops producing insulin, was always fatal. Then, in 1922, scientists from the University of Toronto gave the first injection of insulin to a 14 year old boy with type 1 diabetes. The experiment was a success and one of the major achievements in the history of medicine. However, this would be the first of many steps in fighting diabetes mellitus. Two of the scientists, Dr. Frederick Banting and Professor John Macleod won the 1923 Nobel Prize for Medicine which they shared with two other members of their team, Charles Best and Bertram Collip. And a new Nobel Prize winner may be working on an artificial pancreas right now.

The concept of an artificial pancreas or a “closed loop” system is that a diabetic could automatically have their blood sugar analyzed and in real time inject insulin to maintain a normal glycemic level.

artificial pancreas FDA

Researchers are Focusing on the "Artificial Pancreas"

Although there have been many advances with insulin pumps and continuous glucose monitors, the devil is in the details on how to regulate the amount of insulin supplied to the diabetic. It is hardly an easy matter.

Most diabetes researchers are looking into the concept of an artificial pancreas as opposed to replacing the islet cells in the diabetic’s pancreas that create insulin. It is the destruction of a diabetic’s islet cells that causes type 1, insulin dependent, diabetes. The Toronto researchers originally called their discovery “isletin.” Type 2 diabetes, once referred to as “adult onset” diabetes, is currently in epidemic proportions in the United States. It impacts the body differently than type 1 diabetes.

The development of an artificial pancreas requires the use of sophisticated medical devices, many of which are already approved. However, it requires the devices to communicate with each other and the development of an algorithm to measure the right amount of insulin to be administered at the right time. No easy task.

FDA guidance artificial pancreas

Draft Guidance Discusses Clinical Trials & Applications for Approval

It is also a difficult issue to regulate. FDA is responsible for ensuring that any artificial pancreas system is safe for the user. The new draft guidance lays out a step-by-step approach for researchers through the regulatory process, for “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.” The FDA press release states:

“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”

The draft guidance is for an “early version of an artificial pancreas system.” There is a 90 day comment period from the date the guidance is issued (22 June 2011). A seperate guidance on more autonomous artificial pancreas systems is expected to be released by FDA by the end of 2011.

FDA Press Release

Draft Guidance…Low Glucose Suspend (LGS) Device Systems

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On the Blogroll: Top 40 FDA-Related Websites (and tweeters)

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GxP Audit Techniques & Etiquette

May 29, 2011

audit GxP

GxP Audit Techniques and Etiquette

Auditing for quality assurance purposes or for an independent quality assessment has become a necessity for GxP Professionals in the highly regulated life sciences industry. Many companies have highly developed SOPs for auditors but there is no consensus on the basic behaviors of auditors. In this Guest Commentary veteran GxP Consultants Emma Barsky and Len Grunbaum offer their perspectives on how auditors should behave when conducting audits that can easily impact people’s jobs and reputations. I firmly believe that auditors should take their approach very seriously. Recent experiences of my own indicate it is a topic well worth review.

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GxP Perspectives will be taking a break for a few weeks. Everyone should take a break now and then.
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Guest Commentary by Emma Barsky & Len Grunbaum

As consultants in the life science industry, we often serve in the capacity of audit hosts for companies and, as such, have a greater exposure than most to various audit behaviors. We therefore are rarely surprised by inappropriate audit conduct.

GxP audit technique and etiquette

"I put three people
in jail
."

But even our eyebrows were raised when a third-party auditor, who was representing a company doing business with our client, started the audit with, “I put three people in jail.” Was she showing off and justifying her credentials? Was she trying to intimidate our client and us? Both? The result was that no one in the room was impressed or made nervous by such an introduction. If anything, her attitude provided the inspiration for this blog Guest Commentary.

In light of having to conform to technical and ethical standards of one’s profession, an auditor represents himself/herself and group/department he/she belongs to for sure. More importantly, however, the auditor also represents his/her company as a whole, even if representing the auditing company in the role of a consultant. Given that the auditor is often viewed as the company’s due diligence “eyes and ears,” every word and every move that the auditor makes is a reflection on the company he/she represents and on the employees of that company.

So what should one consider when it comes to the audit preparation, conduct and follow-up? Based on our experience (both good and bad), the following tips regarding audit etiquette, if put into practice, will usually leave the auditee with positive impressions regarding the auditor and the company he/she represents, irrespective of the audit’s outcome:

Be prepared – learn as much as you can in advance about the company you will be auditing. At a minimum, this can be accomplished through:

1) reading about the company on its website,
2) having a discussion with those groups and/or individuals who intend to use the company to be audited,
3) doing an internet search to see if there is anything of interest regarding the company to be audited (e.g., warning letters, legal actions), and
4) reviewing previous audit reports if applicable and available.

audit technique GxP

Preparation:
"An audit agenda is the first document the auditee will see"

Stay focused – develop an audit agenda that will center on the business reason(s) for the audit (e.g., qualification/due diligence audit, “for cause” audit, follow-up of a previous audit, investigation). An audit agenda is the first document that the auditee will see, and from this will form an opinion regarding the auditor. Therefore, it is best to have a detailed agenda that is customized in terms of the basis for the audit. This will:

1) demonstrate the auditor’s understanding of the nature of the auditee’s actual and/or potential support as it relates to the auditor’s company,
2) be indicative of the fact that there is no hidden agenda on the part of the auditor, and
3) set the tone for the auditor’s own expectations regarding thoroughness of the auditee’s preparation for the audit.

Be timely – if possible (e.g., you are not conducting a “for cause” audit or an investigation), send the audit agenda to the auditee at least two (2) weeks in advance of the audit. While a company should be prepared for an audit at all times, a timely agenda:

1) allows the auditee time to gather correct and complete information in advance of the audit,
2) permits the auditee to identify and schedule the appropriate individuals who will provide information during the audit, and
3) establishes the auditor’s own standard regarding timeliness for the auditee to provide requested information.

Dress appropriately – while many companies have a casual dress code, we believe that an auditor should always be dressed in a suit because this is a sign of respect and professionalism even in today’s “less than formal” work environment.

GxP audit technique

Avoid Surprises

Avoid surprises – information regarding the number of people attending the audit should be communicated to the auditee as far in advance as possible. More than once, we have seen instances where more people than expected showed up for an audit without warning. Even if the number of people to be hosted changes at the last second, it is the auditor’s responsibility to let the auditee know about it. Anything less than that is viewed as unprofessional.

Be sensitive – recognize the fact that audits are stressful in that they take away from the auditee’s ability to do billable work. Therefore, to maximize on your own effort while being conscious of the auditee’s availability, have all of your questions prepared in advance of interviews (e.g., after reading SOPs or other documents so the questions can be detailed and specific) to minimize the interview time and be flexible if the times for the interviews have to be changed on the spot.

Be fair – sometimes issues are very complicated and overlap multiple processes and/or organizational groups. Thus it is only fair to split the responsibility for misunderstandings/miscommunication and activities “going amiss” between the auditee and the company on behalf of which the audit is being performed.

GxP Audit techniques

Be Fair
'From what we have observed, the auditees often get all the blame'

From what we have observed, the auditees often get all the blame, even though the fault may not be entirely theirs. If you position yourself as someone who takes no sides and listen to all parties involved, you will be in a better position to identify the root cause of the issue(s) and, as a result, help the company you represent to resolve/mitigate them no matter whose fault it is.

Know your stuff – be well-versed with respect to the applicable regulations and be versatile in how regulations can be applied operationally, while still maintaining compliance, in the areas you are auditing.

Be open-minded – if you have not seen a regulation being addressed in a certain way, it does not mean that it presents a regulatory compliance problem. If it ever happens, your only job is to determine whether the unconventional approach, chosen by an auditee, may result in potential data integrity issues.

GxP audit technique

Professionalism:
"exhibiting a courteous and business-like manner during the audit "

Be polite and tactful – is essential. And, therefore, the usage of language becomes a critical part of the audit conduct. Not only should one stay away from inappropriate introductions (such as that described above), but also from 1) arguments, 2) accusations and 3) exhibiting lack of patience. Even if you think the company you are auditing is wrong, stay away from heated discussions. Instead, include your point of view and an explanation, along with the auditee’s position, in the audit report and let the company’s “Operations” deal with the rest.

Also, the auditor’s authority should not be misused – we have seen cases where, due to the auditor’s lack of understanding, the auditees were wrongly charged with something they have not done.

Be open – audit observations and potential audit findings should be discussed with the audit host throughout the audit, rather than just at the close-out meeting or even worse yet, mentioned only in the audit report that the auditee has to respond to.

GxP audit techniques

"Transparency throughout the audit"

Transparency throughout the audit will give the auditee a chance to present additional documentation, provide clarifications and collect supplementary evidence before the end of the audit. Not only will such an approach prevent the auditee from feeling “cheated” or “blind-sided,” but it will also give you, the auditor, a much better idea regarding where the auditee really stands.

Be sensible – unlike many seem to believe, “minimal or no observations” is not necessarily a reflection on your competency. So don’t be afraid to walk out of the audit with “no findings” where findings are not warranted. Remember that even the FDA itself is comfortable to close-out its inspections with no FDA-483s. Furthermore, there should also be a clear difference between auditor’s preferences (e.g., recommendations) and findings that present deviations from the regulations and have a potential impact on the quality of the product and/or process(es).

Be factual – when writing observations, provide enough facts and details to substantiate your findings. It is best to stay away from ambiguities and generalities when describing an issue because nothing frustrates an auditee more than all-encompassing statements that make the issue look worse than it really is.

GxP audit techniques

Review Audit Findings
in a Timely Manner

Be responsive – just like you expect the auditee to respond within thirty (30) calendar days (or business days, depending on the individual company’s requirements) to the audit findings, the auditee is also expecting reasonably prompt feedback from you regarding the audit findings and feedback to the respective auditee’s responses. Therefore, the audit findings, audit responses and any follow-ups should be sent out and/or reviewed in a timely fashion. Not letting the auditee know what the audit status is, even if responses are acceptable, is not an option because contracts often depend on the auditee successfully passing the audit.

The “morale of the story” is that the auditor has a big responsibility towards the company he/she represents and towards the company he/she is auditing. In our opinion, the biggest compliment and validation that the auditor can get is for the auditee to say “you were fair,” findings notwithstanding. In this case, everyone wins.

Emma Barsky
Len Grunbaum
Partners
The Practical Solutions Group, LLC

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FDA has announced a new draft guidance document. Public comment is due by 25 July 2011:

Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators

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On the blogroll: ‘The Hill’ on defunding the health reform law: CBO States Danger to Medicare Drug Funding

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GxP Audit Techniques & Etiquette- Please Comment


FDA Issues 5 New International Warning Letters

May 15, 2011

FDA international warning letters

FDA's Increased International Presence

The “Most Recent Warning Letters” section of the FDA website lists five Warning Letters to international firms. The Warning Letters were posted on May 10 and will disappear into the Warning Letter labyrinth on the website in a few days (see previous post). They are to firms in both Europe and Asia and come from four different centers: the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research (Active Pharmaceutical Ingredient (API); the Center for Biologics Evaluation and Research; and the Center for Food Safety and Applied Nutrition (two Warning Letters for Seafood HACCP).

The Warning Letters do not state if the inspections were conducted by one of the FDA’s new International Resident Posts- but it is likely that the FDA’s increased global presence contributed to the enforcement actions. FDA now has offices in China, India, Belgium, and Costa Rica. This is addition to FDA’s International Inspection Cadre which is primarily drawn from FDA Field Investigators (Consumer Safety Officers) working for the 20 FDA District Offices across the country. The fact that different offices are issuing Warning Letters around the world at the same time gives a clear indication of FDA’s increased international enforcement efforts.

FDA International Resident Posts

Read the Warning Letters:

Hong Kong – Medical Devices

Spain – Active Pharmaceutical Ingredients

Sweden – Biologics cGMP

Korea – Seafood HACCP

On the Blogroll: Last week we had the FDA Lawyer’s Blog. This week I want to highlight a recent article on the FDA Law Blog on “FDA Warning Letter ‘Close Out’ Process Not Working.”

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ACRP Meets in Seattle for 2011 Global Conference

April 29, 2011

ACRP Seattle

ACRP Meets in Seattle for 2011 Global Conference

Seattle, WA plays host to the Association of Clinical Research Professionals’ (ACRP) annual Global Conference. ACRP is one of the larger professional organizations focusing on clinical trials and expects 2,000 participants. It will be the first time I have attended their Global Conference and I am looking forward to it. There will be sessions on “Introduction to Imaging in Clinical Trials” and on “Distance-Based Learning for Foreign Study Coordinators.” GxP Perspectives will be there for the entire conference (the pre-conference workshops have already begun) and among the sessions I look forward to is “Comparative Effectiveness Trials.” I am going to try to blog at least twice during the conference on issues I think are of concern to GxP Perspectives readers. If I am super industrious maybe I will blog from the ACRP Global Conference every day.

Here is a new feature that ACRP is offering:ACRP is pleased to announce that for the first time ever, two live-feed Plenary Sessions from the ACRP Global Conference & Exhibition will be broadcast FREE of charge. Join us May 1 for the Regulatory Affairs Public Forum featuring representatives from global regulatory agencies addressing issues facing clinical trials. Join us May 2 for Innovation & Global Health, a discussion by Tachi Yamada, MD, President, Global Health Program, Bill and Melinda Gates Foundation.

For more information visit the ACRP Website on the Plenary Sessions

ACRP clinical trials

Do You Have a Guest Commentary for
GxP Perspectives?

Another highlight will be the May 1st session on “Your Site Doesn’t Need 60 SOPs, But How Many Does It Need?” The speakers are Christine Pierre, RN and Steven Steinbreuck, MPH and the author of a Guest Commentary on GxP Perspectives on Informed Consent Requirements. Remember, I am always looking for a good Guest Commentary. Send me a note and ask me how-

Leave a Comment to Submit a Guest Commentary!

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On the Blogroll: Top 40 Websites (and Tweeters) on the FDA, by FDAZilla (Yes, we made the list.)

Moriah Consultant’s Blog – Commentary by Michael Hamrell, one of the conference speakers
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Conferences: Pharma/Bio Boot Camp on the eTMF on 20-21 May 2011 in Philadelphia


FDA Inspections: Will FDA’s New Food Safety Authority Leave Drugs & Devices Behind?

December 5, 2010

FDA authority food safety drug device inspection

FDA Food Safety:
How will it Impact Drug and Medical Device Inspections?

With the passage of the FDA Food Safety Modernization Act by the U.S. Senate, there has been concern that FDA will “choke on food” and not have adequate resources to conduct inspections of medical devices, human drugs, and biological products including vaccines. Although the bill still needs to reconciled between the House and Senate versions, funding is clearly going to be an issue as the new Congress is in a belt-tightening mood. Will FDA’s new food safety authority cut back on oversight of clinical trials and other drug and device inspections? This has been a discussion on the GxP Perspectives LinkedIn Group. My viewpoint is that the new food safety authority will not have an impact on Bioresearch Monitoring inspections (GCP & GLP) but probably will for routine GMP inspections of both pharma and device companies.

Why? The Bioresearch Monitoring (BIMO) program coordinates FDA inspections of Clinical Investigators, IRBs, Sponsors and/or CROs, Nonclinical Laboratories, and Bioequivalence/Bioanalytical research. The BIMO (pronounced bye-moe) inspections are coordinated, and payed for, by four FDA Centers; the Center Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) located at FDA’s headquarters in Silver Springs, MD. Remember, they have user fees from the Prescription Drug User Fee Act and the device user fee program. So if you are considering an application for approval, expect an FDA inspection.

Those of us in the drug and device development field often think that FDA’s primary authority is the approval of new health therapies. If you are an FDA employee at one of the Centers in Silver Springs, that just might be the case. However, the primary area the new FDA Food Safety and Modernization Act will impact is in the organization and management of the Office of Regulatory Affairs (ORA- the field organization) and the Center for Food Safety and Applied Nutrition.

FDA food authority drugs devices inspections

Bioresearch Monitoring is 5.4% of ORA's Workplan

Bioresearch Monitoring makes up around 5.4% of ORA’s workplan so it has never been their major focus. FDA has fallen behind in the biennial GMP inspection schedule for years, so I would anticipate that to continue, if not worsen. However, the mandated, and funded, inspections of clinical trials should continue unabated. Here are the numbers from the ORA Fiscal Year 2009 Workplan. (The new tobacco program is not included.) They show that food is the largest program. It always has been. ORA is funded by the Centers by the number of FTEs (full time equivalent employees) allocated by the centers to conduct inspections and laboratory analyses.

Food: 1,062 FTEs – 53% of Total
Human Drugs: 339 FTEs- (62.1 BIMO FTEs)
Medical Devices: 238 FTEs- (36 BIMO FTEs)
Vet Medicine: 118 FTEs- (4.4 BIMO FTEs)
Biologics: 115 FTEs- (4.4 BIMO FTEs)

TOTAL: 1,987 FTEs- (106.9 BIMO FTEs) – 5.4% of Total FTEs

These numbers tell an interesting story. ORA has 20 District Offices around the country. They also now have international offices for China, India, Europe, and Latin America. However, the primary focus is food, GMP, and import operations, not BIMO. Think about the amount of expertise and specialization the drug and device development industries require. There are times when one of the Centers will send specialists to work with an FDA BIMO Investigator. That is taking place more and more for sponsor inspections. Still, look at the numbers and do the math.

FDA food safety authority drug device inspections

FDA Needs Adequate Funding for Food, Drug & Device Inspections

I support passage of the FDA Food Safety Modernization Act. It will help FDA take Salmonella off of grocery store shelves and as a consumer I appreciate that. However, it is possible that drug and device GMP inspections might suffer. FDA BIMO inspections will continue at the same rate, but I am one to support a BIMO Modernization Act to help FDA update regulations and reorganize the inspection force. Most of all, FDA needs the funding to carry out the Food Safety Act as well as its other responsibilities, including GMP inspection of drug and device manufacturers and clinical trials.

ORA Workplans FY-2001 thru FY-2009

Update: Read Steven Grossman in FDA Matters on two strategies for FDA legislation in 2011.

>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Two Important New GCP Documents: There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

Please join GxP Perspectives on LinkedIn at:

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Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.

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In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA.


FDA Sends J & J a Warning Letter For Internet Marketing- Forest Labs Agrees to Pay $300 Million for Violating FDA Laws

August 30, 2010

website FDA Warning Letter J&J

internet Marketing Cited in FDA Warning Letter

Johnson and Johnson subsidiary, DePuy Orthopedics, received an FDA Warning Letter for marketing violations. The Warning Letter cites DePuy for internet marketing of their products without FDA approval. The Warning Letter is one more headache for J&J that is discussed in the post from 19 August on J&J’s Quality Control Headaches. The Warning Letter states:

“The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website, http://www.depuyorthopaedics.com. for the TruMatch™ Personalized Solutions System and the Corail® Hip System.”

Read the Warning Letter to DePuy

View J&J’s Current Webpage on Hip Replacements

UPDATE: J&J is not the only company in hot water with FDA for marketing. Forest Laboratories has agreed to a $300 Million settlement for the following: “Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.”

FDA Press Release on Forest Labs

Read “J&J’s Quality Control Headaches”

On The Blogroll: Again, I would like to highlight some of the blogs found on the blogroll to the right. This blog focuses on public health, The Pump Handle.

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

In news from GxP Perspectives read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

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FDA Inspections: How Long Should They Take?

May 30, 2010

how long FDA inspection

How long should an FDA Inspection take?

How long will an FDA inspection take? Three days? Three weeks? Three months? Are there any rules? The most recent FDA Warning Letter to a clinical site was released last week and it was for some rather typical violations. Failure to obtain informed consent. Enrolling subjects who met exclusion criteria. Failure to report concomitant medications. These violations were compounded by the fact the clinical investigator failed to adequately answer the Form FDA 483, Inspectional Observations. They had not specified how they were going to meet proposed corrective and preventative actions (CAPA). None of these issues really caught my attention. The Warning Letter, issued by the Center for Devices and Radiological Health, seemed entirely appropriate.

What leaped out at me, however, was the fact that the inspection had taken place over two and a half months. The inspection began September 14, 2009 and was completed on December 2nd. The Warning Letter was not that lenthy or complex. Why did it take such a long time? FDA primarily regulates clinical trials at the clinical sites. Unlike a pharmaceutical or medical device company, not all clinical sites are equipped to host an FDA inspection over a ten week period. Although some clinical sites are for-profit clinical research centers, others are busy medical clinics with limited resources to handle a ten week inspection. Is this imposing an unnecessary regulatory burden on clinical sites? Two and a half months hosting an FDA inspection can cost a Lot of time, money and resources.

How long should FDA Inspections take

What are Reasonable Hours for Inspection?


I have recently heard anecdotal evidence of one recent FDA inspection taking place over a six week period at a busy medical practice. the FDA field investigator was not at the site half of the time during the inspection while performing other duties. That can be difficult to arrange staff to assist the inspection. Another inspection lasted until 9:00 pm, a good 4 hours after the clinic’s business hours were over. Is that “at reasonable times” as specified by 21 CFR 312.68?

length of FDA inspections, how long?

Should There be Timeframes for Warning Letters?

Another item of interest is the length of time between the end of the inspection and the issuance of the Warning Letter. I worked on a temporary assignment at FDA headquarters in 2004. Then, there were strict timeframes when a Warning letter needed to be issued after the conclusion of an inspection. That evidently is no longer the case. For example, the Division of Scientific Investigations issued a Warning Letter on February 24, 2010 for a 3-day inspection that concluded on March 27, 2009. That’s almost a year. And it is hardly the only example. Is this an appropriate policy? Planning for an FDA inspection isn’t easy. knowing the approximate length might be helpful for smaller clinics.

You can read about FDA Warning Letters to clinical investigators on FDA’s Website. You can search by subject for “Clinical Investigators” for inspections assigned by the Center for Drugs and under “Investigational Device Exemptions (Clinical Investigators) for medical devices.

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On the Blogroll: FDA Matters discusses The Hamburg Legacy in consideration of one year as FDA Commissioner for Dr. Margaret Hamburg.

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