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Pharmaceutical Industry › Food and Drug Administration (FDA) › Federal Register

Stevens & Lee

FDA Guidance on Drug Compounding for Veterinarians and Pharmacists

Stevens & Lee on

The Guidance published in the Federal Register last April for “veterinarians, State-licensed pharmacies, and Federal facilities” regarding compounding animal pharmaceuticals will take effect April 2023. The guidance focuses...more

Arnall Golden Gregory LLP

What's Old is Not New Again . . . HHS Rescinds FDA's Unapproved Drug Initiative Program

Arnall Golden Gregory LLP on

On November 20, 2020, the United States Department of Health and Human Services (HHS) issued a Federal Register notice to: (1) withdraw the Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG) Sec. 440.100...more

Hogan Lovells

FDA pushes "consumer-friendly" presentation of quantitative data in DTC promotions

Hogan Lovells on

On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more

Mintz - Health Care Viewpoints

FDA Releases Series of Gene Therapy Guidance Documents: From Drug Development to Postmarket Monitoring

Mintz - Health Care Viewpoints on

In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval...more

Hogan Lovells

FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)

Hogan Lovells on

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in...more

Hogan Lovells

Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads

Hogan Lovells on

On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more

McDermott Will & Emery

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

McDermott Will & Emery on

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

Patterson Belknap Webb & Tyler LLP

First Federal Register Notice of BPCIA Suit

Patterson Belknap Webb & Tyler LLP on

Yesterday, FDA published notice of Janssen’s lawsuit against Celltrion and Hospira on March 6, 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in the Federal Register. Although Janssen’s lawsuit...more

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