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Venable LLP

Implications of Loper Bright for FDA-Regulated Products

Venable LLP on

Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more

Foley Hoag LLP

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

Foley Hoag LLP on

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more

Foley Hoag LLP

Information Collection Request for Drug Price Negotiation Program Data Elements

Foley Hoag LLP on

On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more

Hogan Lovells

O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

Hogan Lovells on

Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more

Akin Gump Strauss Hauer & Feld LLP

Preparedness Policy Takes Shape: PREVENT Pandemics Act Enacted Ahead of PAHPA Reauthorization

On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....more

Latham & Watkins LLP

Food and Drug Omnibus Reform Act Introduces Key Changes to FDA’s Authorities

Latham & Watkins LLP on

The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers. Key Points: ..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more

King & Spalding

Act II: The Senate Unveils Its Draft

King & Spalding on

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

Hogan Lovells

FDA explains when medical device makers must notify of an interruption in manufacturing

Hogan Lovells on

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more

King & Spalding

The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps

King & Spalding on

Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P...more

Hogan Lovells

First company receives FDA violation notice for ClinicalTrials.gov submission omission

Hogan Lovells on

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more

Mintz - Health Care Viewpoints

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more

ArentFox Schiff

Legislative Changes to FDA’s Orange Book and Purple Book Listing Requirements

ArentFox Schiff on

Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements. Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the...more

McDermott Will & Emery

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

McDermott Will & Emery on

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more

MoFo Life Sciences

Pediatric Exclusivity For Biologics

MoFo Life Sciences on

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy...more

K&L Gates LLP

K&L Gates Triage: Q&A: What Sponsors and Investigators Need to Know about FDA’s ClinicalTrials.gov Reporting Requirements

K&L Gates LLP on

FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Burns & Levinson LLP

CBD as a Dietary Supplement – A Potential Regulatory Avenue for Retail Hemp Operators Selling THC Extracts

Burns & Levinson LLP on

On January 13, 2020, Representative Collin Peterson, the Chairman of the House Agricultural Committee, introduced a new bipartisan bill, H.R.5587 (Bill 5587), in the U.S. House of Representatives that would potentially...more

Faegre Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

Mintz - Health Care Viewpoints

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more

Steptoe & Johnson PLLC

FDA Holds First Public Hearing on CBD Regulation

As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more

Goodwin

New FDA Biosimilar Guidances and Proposed Rule

Goodwin on

Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents - the draft guidance titled “The ‘Deemed to be a...more

Bergeson & Campbell, P.C.

House Passes Pandemic And All-Hazards Preparedness And Advancing Innovation Act of 2018

On September 25, 2018, the U.S. House of Representatives passed without objection the Pandemic and All-Hazards Preparedness And Advancing Innovation Act of 2018. Introduced on July 16, 2018, by Congresswoman Susan W. Brooks...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

Foley & Lardner LLP

Can FDA Implement The BPCIA As The CAFC Suggested?

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In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Goodwin

“Deemed to be a License” Provision Poses Potential Issues for Biological Products

Goodwin on

The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”)....more

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