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FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

USA, European Union - August 5 2019 On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to...

Christopher Fanelli, Lowell Zeta, Scott Kaplan, Elisabethann Wright, James R. Johnson.

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

USA - May 29 2019 On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act)...

Susan M. Cook, Heidi Gertner, Sydney Fairchild, Lauren S. Colton, David M. Fox.

FDA guidance may ease path to biosimilar interchangeability

USA - May 15 2019 On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to...

Jason F. Conaty.

FDA publishes final guidance on ANDA505(b)(2) NDA pathways

USA - May 10 2019 On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor...

George A. O'Brien.

China adds 30 drugs to its "urgently needed" list

China - April 2 2019 Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications. On 28 March China's...

Xin Tao, James R. Johnson.