So You Want To Be A Regulatory Affairs Professional?

The full post is a nice read and synopsis of the trends over the past 10-20 years.

So You Want To Be A Regulatory Affairs Professional? : Bio Job Blog:

 

"We have seen increased movement of professionals across product lines—from more pharma-oriented jobs to medical device jobs and vice versa, and we have witnessed increased involvement in combination products. We have seen a trend away from country-specific specialization to more professionals who have multinational or worldwide responsibilities. And we see strong similarities in the scope of practice of professionals around the world, regardless of where they live and work. Today’s regulatory professionals have to be more familiar with regulations and requirements for many different global markets and different products." 'via Blog this'

FDA changes to drug bar code rule could have significant impact on packaging lines

This is a good read, touching on several interesting aspects of bar codes on packages.

FDA changes to drug bar code rule could have significant impact on packaging lines | Anti-counterfeiting, track-and-trace, authentication | Healthcare Packaging:

"Manufacturers have been particularly outspoken about the need for the FDA to update the 2004 bar code rule. "Abbott recommends that FDA not require one specific bar code type but instead select GS1's approved data carriers," says Mark J. Goldberger MD, MPH, divisional vice president, regulatory policy & intelligence, Abbott Laboratories. "Using GS1 standards, manufacturers could choose the appropriate data carrier type for the package size and market."

GS1, the international standards organization, allows for serialization within its Global Trade Identification Number (GTIN), provides a 2D standard called GS1 DataMatrix and a stacked, linear bar code called GS1 DataBar. Very few American pharmaceutical manufacturers are printing GS1 DataMatrix labels today and even fewer are serializing them, as California will require. Some are printing GS1 DataBar, which is a small pyramid of stacked linear codes, referred to as a "composite" code. It is rarely serialized but could be."

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How much GMP training is “enough”?

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GMP Coaching, How much GMP training is “enough”? Fair...:

"Listen, lack of documented GMP training has been one of the most common FDA Inspection findings so far. “Documented” Training? Yes, the company must have an updated list on file of all training received by every employee.  Expect an FDA inspector to ask to see your training log during the course of the inspection (good reason to make employee GMP Training your top priority) If you don’t keep your training log up to date, the FDA will say that the training never happened. That’s their approach, so be ready."

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Good points above.  Some training experts might suggest anything from 4-8 hours of training a year to meet "enough."  Also consider, if the company has more deviations, or 483 observations, then that might suggest the need for even more training hours.

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Gluten in Drug Products - FDA Request for Info

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The Food and Drug Administration (FDA) is gathering information on drug ingredients derived from wheat, rye or barley, to help people with celiac disease make better-informed decisions when buying drugs and other health products.

Specifically, the FDA is asking pharmaceutical companies for information about any ingredients derived from wheat, rye or barley, that are used to make U.S. products.  According to the:

Federal Register | Gluten in Drug Products; Request for Information and Comments:

"The Food and Drug Administration (FDA) is announcing the establishment of a docket to obtain information and comments that will assist the Agency in its deliberations about ways to help individuals with celiac disease avoid the presence of gluten in drug products. In particular, FDA is interested in information on ingredients present in human drug products marketed in the United States that are currently derived from wheat, barley, or rye."

'via Blog this'

We've discovered gluten intolerance in our household, so this has some interest to us.

For more FDA information about gluten:
FDA: 'Gluten-Free' Now Means What It Says

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FDA to review inhalable caffeine

Even though the product is sold as a dietary supplement, the FDA is showing some interest in reviewing its safety & legality.

APNewsBreak: FDA to review inhalable caffeine - WSJ.com:

 

"U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement. AeroShot went on the market late last month in Massachusetts and New York, and it's also available in France. Consumers put one end of the canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly." 'via Blog this'

Roche Says Counterfeit Cancer Drug Avastin Being Investigated by FDA

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Roche Says Counterfeit Cancer Drug Avastin Being Investigated by U.S. FDA - Bloomberg:

"Roche and the Food and Drug Administration are seeking to prevent the fake cancer drug, which doesn’t include the active ingredient bevacizumab, from being distributed further, the company’s Genentech unit said in an e-mail late yesterday. The FDA notified the company about the issue in December, said Edward Lang, a spokesman for Roche’s South San Francisco, California-based unit.

“We’re working with the FDA, as well as with law enforcement authorities to aid in their investigation,” Lang said today in an interview. “We’ve analyzed some of the vials, we found no therapeutic protein there. So there’s no Avastin, there’s no generic form of Avastin.”"

'via Blog this'

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CDC - Seasonal Influenza (Flu) - Weekly US Map: Influenza Summary Update

The 2012 flu season is here.   Unfortunately for me, the flu is considered widespread in my state, California.

Checkout the CDC's flu map:

CDC - Seasonal Influenza (Flu) - Weekly US Map: Influenza Summary Update:  'via Blog this'

For more information, visit:
The CDC - Seasonal Influenza: Flu Basics

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Critical Shortage of Children's Leukemia Drug

It's very concerning and a shame that we even have this situation.

Critical Shortage of Children's Leukemia Drug - ABC News:

"Medication used to treat the most common form of childhood leukemia is in short supply, adding to the largest nationwide shortage of critical lifesaving hospital medications in nearly a decade.

All five pharmaceutical companies that make the injection drug methotrexate, which treats acute lymphoblastic leukemia by slowing the growth of cancer cells, have either slowed and stopped manufacturing of the drug, according to the U.S. Food and Drug Administration. The companies have cited high demand or manufacturing delays as reasons for the shortage.

If the shortage continues, physicians and pharmacists fear thousands of children will be left without lifesaving treatment."

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FDA issues draft guidance on biosimilar product development

Press Announcements; FDA issues draft guidance on biosimilar product development:

"The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.”"

'via Blog this'

According to the press release, these are the 3 new draft guidance documents:

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: The draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application, called a “351(k)” application, to the FDA. This draft guidance describes a risk-based “totality-of-the-evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of the proposed product to the reference product. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product: The draft guidance provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. This includes the importance of extensive analytical, physico-chemical and biological characterization in demonstrating that the proposed biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: The draft guidance provides answers to common questions from people interested in developing biosimilar products. The question and answer format addresses questions that may arise in the early stages of product development, such as how to request meetings with the FDA, addressing differences in formulation from the reference product, how to request exclusivity, and other topics.

For more information:

• FDA: Biosimilars

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

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2011 FDA Warning Letter Review

Updated August 21, 2023

The original link broke.

You might also be interested in:

FDA Warning Letters - FDA.gov

---  the original post follows below  ---

Potentially more GMP trouble ahead for the dietary supplement industry.

2011 FDA Warning Letter Review: The Rise of GMPs:

 

"GMP violations dominated dietary supplement warning letters issued by the Food and Drug Administration in 2011, from failure to establish product specifications to poor record keeping, reveal FDA legal specialists Ivan Wasserman and La Toya Sutton. 2011 saw a sharp rise in cGMP-related FDA warning letters In 2010, we saw the first warning letters for dietary supplement current Good Manufacturing Practices (GMP) violations. In 2011, the number of GMP related letters soared, representing half of the total warning letters issued by the agency. In our annual review, we identified a total of 68 warning letters concerning dietary supplement products in 2011:" 'via Blog this'

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FDA Inspectors Crave a Good Hot Cup of CAPA

Looks like companies are still having the same problems.

FDA Inspectors Crave a Good Hot Cup of CAPA:

"An analysis of 2011 and 2010 FDA inspection observations in 483s shows clearly that CAPA remains at the top of the charts for the FDA (see charts below). FDA’s own analysis of its 3,434 483 observations in 2010 found that CAPA was the number one, with a total of 1058 citations. Number for 2011 aren’t yet available, but there’s no indication they are going anywhere but up. And that’s probably not going to change in 2012, either."

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It's Here! 2012 FDA Orange Book!

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

It finally arrived!

The FDA Orange Book for 2012 (32nd Edition)  has just been posted. It's current through Dec 31, 2011.

It's also posted in this location:
FDA - Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations: Publications

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FDA and industry reach agreement in principle on medical device user fees

The agreement in principle is the result of over a year of negotiations between the FDA and industry. It strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability, and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants. With the additional funding, the FDA would be able to hire over 200 full-time equivalent workers by the end of the five-year program. The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.

Press Announcements - FDA and industry reach agreement in principle on medical device user fees:

"FDA and industry reach agreement in principle on medical device user fees The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon. Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame."

'via Blog this'