Search results for "FDA"
Article
Innovative Therapies Require Modern Manufacturing Systems
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and agency officials expect this pace to continue. Manufacturers are testing a full pipeline of importa…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA is considering at least three CAR-T applications, and more are on the way. An FDA advisory committee voted unanimously to recommend approval of Novartis’ new CAR-T, despite concerns about the firm…
Article
Biopharma Seeks Balance
To increase the potential for approval, companies need to provide better “packages” that describe how the drug works, said Scott Gottlieb, FDA commissioner, at the 2018 BIO convention in Boston on Jun…
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Bracing for a Future Wave of Advanced Therapies
If you go back in time to 2019 when FDA … said we could see 10 to upwards of 20 approvals a year starting in 2025, we think that is tracking rather nicely for that time period. It’s conceivable that w…
Article
Drug Quality Key to Innovation and Access
Innovation and reform
Pressure will mount on FDA under the new administration to make experimental therapies available to patients faster and more predictably. As 2016 came to a close, FDA officia…
Article
Breakthrough Drugs Raise Development and Production Challenges
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA program to expedite the development and approval of innovative drugs for serious and life-threat…
Article
Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…
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Manufacturers Struggle with Breakthrough Drug Development
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs” that offer exceptional promise in treating patients with serious medical needs. Such designa…
Article
Biosimilar Quality Requirements
By Feliza Mirasol
Recent guidelines released by FDA emphasize the agency’s efforts to ease the path toward regulatory approval for biosimilars and marks significant action taken by the agency to h…
Article
Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…