News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Investigational New Drug Application (IND)

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

Womble Bond Dickinson

Emergency Use Authorization Issued for COVID-19 Antibody

Womble Bond Dickinson on

On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...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

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

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

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Arnall Golden Gregory LLP

You Can’t Put That Tissue There: FDA Clarifies Important HCT/P Regulatory Criteria

One of the first warning letters of 2018 was issued to a manufacturer of a human cell, tissue, and cellular and tissue-based product (HCT/P) that the Food and Drug Administration said was regulated as a drug, and as a...more

Hogan Lovells

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Hogan Lovells on

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

King & Spalding

FDA Issues Draft Guidance Addressing Communications with Payors

King & Spalding on

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

FDA Streamlines the Expanded Access Approval Process for Individual Patients

The U.S. Food and Drug Administration (FDA) just made it easier for physicians to get critically needed, but not yet approved in the U.S., treatments to some of the nation’s most critically ill patients. FDA Commissioner...more

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