News & Analysis as of

Investigational New Drug Application (IND) 21st Century Cures Act

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 10. In This Month’s E-News: October 2022

Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more

Wilson Sonsini Goodrich & Rosati

A Preliminary Evaluation of the RMAT Designation's Effect on Publicly Traded Company Stock Price

The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative medical therapies. An RMAT designation conveys significant regulatory...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

Wilson Sonsini Goodrich & Rosati

The Regenerative Medicine Advanced Therapy (RMAT) Designation and Its Importance to New Product Development

The 21st Century Cures Act enacted the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative therapies. Qualifying for RMAT designation conveys significant...more

Fox Rothschild LLP

What The 21st Century Cures Act Did For Regenerative Medicine

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Under Section 3033 of the 21st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (“RMAT”) designation. To obtain this designation, the treatment must be “a cell therapy, therapeutic tissue...more

Hogan Lovells

Ready, Set... Cures Act Expanded Across Policy Deadline Is Almost a Go

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As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain investigational drugs publicly available....more

Cooley LLP

Blog: Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting...

Cooley LLP on

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access...more

King & Spalding

FDA Issues Draft Guidance Addressing Communications with Payors

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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

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