Regulatory Affairs

19
Apr
April 2024 FDA SBIA Generic Drug Forum – A Flair for the PLAIR - Lachman Blog

April 2024 FDA SBIA Generic Drug Forum – A Flair for the PLAIR

Last week, I was able to attend SBIA’s Generic Drug Forum in Bethesda, Maryland, and I’m sure that many readers of Lachman’s blog also attended virtually. The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities […]

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19
Apr
Barriers to Parallel Scientific Advice Hurdles - Lachman Blog

Barriers to Parallel Scientific Advice Hurdles May Be Too High!

Although the pilot program for Parallel Scientific Advice (PSA) meetings with U.S. and the EMA for complex generics and hybrid products is relatively new, there have been only two requests for meeting participation thus far. According to the FDA, “The Parallel Scientific Advice (PSA) pilot program allows for applicants to engage in concurrent scientific conversation […]

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16
Apr

FDA SBIA Generic Drug Forum 

What is the answer to the question?  Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC).  The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]

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12
Apr
Drug Shortages – No Solution in Sight - Lachman Blog

Drug Shortages – No Solution in Sight!

At the Association of Accessible Medicines (AAM) February 2024 Annual Meeting Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director of CDER, made another interesting point in her presentation yesterday, outlining the number of national drug shortages that the FDA reported per calendar year (reproduced at the link below) and indicating that the press has reported […]

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11
Apr
OGD Posts Its Official February 2024 Monthly Statistical Report - Lachman Blog

OGD Posts Its Official February 2024 Monthly Statistical Report

This month we will pat ourselves on the back as we captured the correct number of approval and tentative approval actions in our calculation of the unofficial numbers in our post here. We were more patient when looking at the February data from the daily approval page (which must be pieced together because it only […]

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04
Apr
New Cephalosporin Class Antibiotic Approved by FDA for Three Uses - Lachman Blog

New Cephalosporin Class Antibiotic Approved by FDA for Three Uses

It’s not the big things that you need to worry about; it’s the little things that will kill you! And nothing is truer than that when it comes to microbial bugs that have become resistant to antibiotic therapy! The rise in “Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the […]

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02
Apr

Ophthalmic Drug Product PSG Publishes Under Unusual Circumstances 

Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here).  As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]

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27
Mar

FDA Warns of Danger for Unapproved Topical Products Containing Lidocaine 

In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs.  The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.”  These products are being marketed at concentrations above […]

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