March 2017

31
Mar

Paul F. Vogel retires as Chairman of the Board, Richard S. Bowles, III, Ph.D. assumes the role

Paul F. Vogel has announced his retirement as Chairman of the Board of Lachman Consultants, effective March 31, 2017. Paul plans to spend more time with family and his many personal interests, following a 44-year career that included 21 years at the U.S. Food and Drug Administration followed by 23 years at Lachman Consultants. Richard […]

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29
Mar

Here’s Good News, Sports Fans – Submission Dates are Back in Approval letters

Ever since I can remember, the submission date of an ANDA has been reported in the approval letter of the application.  That practice stopped in early 2016, as reported in our blog post (here). The submission dates of applications are important metrics that help the industry to track approval times for applications.   We heard a […]

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28
Mar

GXP Data Flow and Security – FDA’s Looking for Sure!

It’s late, do you know where your data is?  Are you really sure?  Would you be able to assure a regulatory agency that you fully understand and control the flow of data from data generation through processing, reporting, data review, archive and retrieval?  If the answer to all the above questions is yes, congratulations!  Unfortunately, […]

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21
Mar

Hey, Wait a Minute Here! Are the UFAs in Danger?

Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews.  Am I seeing this correctly?  Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs […]

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20
Mar

BE Recommendation Revision Again Demonstrates OGD Recognition of Q1 and Q2 Value

OGD has revised its bioequivalence (BE) recommendation for rifaximin 200 mg and 550 mg tablets. Quite interestingly, the requirements for products that are qualitatively and quantitatively (Q1 & Q2) the same as the reference listed drug (RLD) will have a reduced burden and may eliminate conducting bioequivalence studies with clinical endpoints (albeit pharmacokinetic [PK] studies […]

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15
Mar

Challenges and Advantages of International Regulatory Inspections, by Dan Barreto, VP, Compliance

Every year, FDA and key worldwide regulatory authorities perform foreign inspections of production facilities around the world. All inspections share a common goal: to ensure the products shipped to their respective countries will comply with the core requirements for safety, efficacy, quality, purity, and regulatory commitments. While foreign regulatory agencies merit respect, the FDA and […]

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