Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

FDA and Justice Department Address Drug Quality Concerns

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.
Feb 1, 2012

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Budget Crunch, Political Battles Shape Policy Agenda for Year

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.
Jan 1, 2012

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

FDA Revamps to Meet New Challenges

Added responsibilities and outside concerns prompt overhaul of agency's structure.
Dec 1, 2011

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Drug Shortages Create Crisis for Manufacturers, Regulators

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.
Nov 1, 2011

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.

Global Health Challenges Spur Vaccine Development

Manufacturers fund research and reduce prices to tackle diseases around the world.
Oct 1, 2011

Manufacturers fund research and reduce prices to tackle diseases around the world.

Manufacturers and FDA Gear Up for User-Fee Action

PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.
Sep 1, 2011

PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.

FDA Maps Strategy to Counter Supply-Chain Threats

Rising imports, overseas production spur collaboration and realignment of enforcement activities.
Aug 1, 2011

Rising imports, overseas production spur collaboration and realignment of enforcement activities.

FDA and Manufacturers Ponder Biosimilars Pathway

Follow-on versions of complex biologics require extensive expertise.
Jul 1, 2011

Follow-on versions of complex biologics require extensive expertise.

Safety Concerns and Shortages Challenge Pharma Manufacturing

Industry struggles to curb drug abuse, diversion, and disruptions in supply to ensure access to quality products.
Jun 1, 2011

Industry struggles to curb drug abuse, diversion, and disruptions in supply to ensure access to quality products.

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