The Lachman Blog

23
May

Are FDA’s Approval Authority and Agency Deference at Risk? Mifepristone Ruling and Beyond

The Food and Drug Law Institute (FDLI) recently held its 2023 Annual Conference on May 17-18 in Washington, D.C. where professionals from the food, drug, medical device, biologics, and tobacco industries gathered to hear important updates and panel discussions from a distinguished group of industry and FDA speakers.  The Conference commenced with keynote addresses by […]

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22
May

Exclusivity from the Experts

One of the breakout sessions offered at the recent FDLI conference was titled, Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs and Biologics.  The panel for this session included representatives from FDA, industry, and attorneys that specialize in this practice area.  While the session covered both patent and exclusivity issues, I will be […]

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22
May

Meet Lachman Consultants (Ireland) at the 2023 PDA Good Aseptic Manufacturing Conference

Join Lachman Consultants (Ireland) in Leipzig, Germany for the 2023 Parenteral Drug Association (PDA) Good Aseptic Manufacturing Conference on May 23 – 24, to discuss the implications of the new GMP Annex 1 and share insights to help you prepare. As a Gold Sponsor at this year’s event, Lachman will be represented by: John Darby, […]

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22
May

FDLI Session Addresses the Nitrosamine Issue

Hundreds of FDA staff, industry professionals, lawyers, and others gathered in Washington, D.C. on May 17th and 18th to participate in the 2023 Food and Drug Law Institute (FDLI) Annual Conference.  The agenda covered a broad range of current regulatory and legal issues facing the food, drug, medical device, biologics, and tobacco industries.  Lachman Consultant Services […]

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19
May

Petition Tests OGD Guidance on Use of Males and Females in BE Study

A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]

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18
May

FDA Releases New and Revised BE Product Specific Guidances

Today, the FDA released another batch of Product‑Specific Guidances (PSGs), outlining its current thinking on the bioequivalence (BE) testing requirements for generic products – twenty‑five new BE guidances and twenty‑one revised guidances.  The listing can be found here. The FDA has various goals regarding publication of these PSGs that are tied to getting information to […]

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