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."

'via Blog this'

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How much GMP training is “enough”?

• Advanced FDA GMP online training courses & programs offered by SkillsPlus International Inc.

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."

'via Blog this'

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'