News & Analysis as of

Pharmaceutical Industry Federal Register

Axinn, Veltrop & Harkrider LLP

Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices?

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more

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

ArentFox Schiff

Physician Fee Schedule Proposed Rule for 2023 Released: What Pharmaceutical Manufacturers Need To Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more

Arnall Golden Gregory LLP

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

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

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...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On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more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

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been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development and approval...more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

Troutman Pepper

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

Troutman Pepper on

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

Pierce Atwood LLP

EPA Proposes Changes to Hazardous Waste Generator Rules and a New Management of Hazardous Waste Pharmaceuticals Rule

Pierce Atwood LLP on

The U.S. Environmental Protection Agency (EPA) is proposing two new hazardous waste rules that EPA believes will strengthen environmental protection and reduce regulatory burdens. The first is an update to the hazardous...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

Ballard Spahr LLP

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

Ballard Spahr LLP on

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

Patterson Belknap Webb & Tyler LLP

First Federal Register Notice of BPCIA Suit

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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