Regulatory Affairs

30
Apr
More on the Final Rule on ANDAs and 505(b)(2) Applications Image

Final Rule on IVDs Issued, Along with Two Guidance Documents 

FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here).  This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023.  FDA explains that since  “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]

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29
Apr
Mortar and Pestle

New ISPE Guide on 503A Compounding

For anyone who wishes to gain a better understanding of all the complexities of running a 503A compounding pharmacy, a new resource is now available.  The International Society of Pharmaceutical Engineering (ISPE) recently published a new Guide titled “Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies” (here). Some of you reading […]

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24
Apr
Revised QA Document on Promotional Activities for Biosimilars Released by FDA - Lachman Blog

Revised Q&A Document on Promotional Activities for Biosimilars Released by FDA

Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]

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