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Life Sciences › Investigational New Drug Application (IND) › Biologics

Goodwin

FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

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On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about...more

Arnall Golden Gregory LLP

Don’t Pay the Ferryman, Don’t Even Fix a Price: FDA Issues Draft Revision to Its Questions and Answers Guidance About Charging for...

Arnall Golden Gregory LLP on

In 1982, Chris de Burgh (of “Lady in Red” fame) sang, “Don’t pay the ferryman, don’t even fix a price until he gets you to the other side,” where the narrator warns the passenger not to pay the ferryman (because a storm...more

Hogan Lovells

FDA offers new guidance on charging for investigational drugs

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On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to FAQs about FDA’s policies for charging...more

Hogan Lovells

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

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Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more

Hogan Lovells

Time’s up: New enforcement era for regenerative medicines begins June 1 - CBER reiterates May 31 end for HCT/P compliance “grace...

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On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they...more

Morgan Lewis

A Rose by Any Other Name? FDA Renames and Restructures Office of Hematology and Oncology Products

Morgan Lewis on

As part of the US Food and Drug Administration’s (FDA’s) overall reorganization of the Office of New Drugs, the former Office of Hematology and Oncology Products (OHOP), the FDA office responsible for approving cancer...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Mintz - Health Care Viewpoints on

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

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