The Lachman Blog

23
Aug

PDUFA VII – Getting Ready for the Reauthorization

Today, in the pre-publication of the Federal Register (here), the Agency announced a notice of public meeting to receive comments and discuss the material negotiations that have taken place between the industry stakeholders and itself.  The notice provides an interesting historical look at the evolution of the PDUFA program since its initial 5-year iteration in […]

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20
Aug

Big Day for FDA and OGD Bioequivalence Information

Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here).  This 42‑page guidance supersedes the December 2013 draft guidance of the same name.  The document provides updated recommendations and the FDA’s current thinking on the general concepts for […]

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13
Aug

2022 PDUFA Fees Announced

After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here.  So, this ends the announcements for the 2022 UFAs and you can take that to the bank! The new PDUFA […]

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12
Aug

Ever See a PANDA In Real Life?  Of Course You Did – You May Even Own One!

In today’s prepublication of the Federal Register listing (here), there is a notice asking for stakeholder comments on the treatment of pre-1962 applications approved as ANDAs that were actually (unbeknownst to most) submitted under section 505(b) of the Act and approved under section 505(c) of the Act, like an NDA.  The historical issues leading to […]

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10
Aug

Limited, Inordinate, and Extended Can Kicking?

On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing […]

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09
Aug

Have an Approved NDA or ANDA for a Contrast Agent or Other Similar Device? Better Read This!

In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government […]

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06
Aug

Skinny Label Is Still Losing Weight – Can It Survive or Will It Starve to Death?

In previous posts here and here, we outlined the attack on the carveout provisions of the Hatch-Waxman Act (also lovingly known as the “skinny label”) that the crafters of the Act included to ensure that generic drugs could get to consumers if there were certain patents or exclusivity issues that would otherwise block entry into […]

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