Latest Posts › FDA

Share:

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Can FDA Implement The BPCIA As The CAFC Suggested?

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

FDA Panel Shows Strong Support for a Remicade Biosimilar

The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more

FDA’s Proposed Naming Convention for Biologics

On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more

FDA Takes Steps to Declare Partially Hydrogenated Oils No Longer GRAS and Seeks Comments

On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for any use in food. PHOs are...more

11/8/2013  /  FDA , Food Safety , Trans Fat

Medical Device Industry Responds to FDA's Overseas Clinical Trial Proposed Rule

In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more

6/17/2013  /  Clinical Trials , FDA , Medical Devices

FDA's Plan to Regulate LDTs

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

FDA Announces Publication of Two Proposed Rules Implementing the Food Safety Modernization Act

On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011....more

9 Results
/
View per page
Page: of 1

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.