Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

Communications Advances Present Challenges to Manufacturers

Social media use raises questions about applying old standards to new information technology.
Mar 1, 2012

Social media use raises questions about applying old standards to new information technology.

FDA Unveils Guidance for Biosimilar Development

Feb 14, 2012

After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

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.

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