Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

REMS Program Challenges Manufacturers, Providers

Too many REMS cause headaches for doctors and the industry.
Sep 1, 2010

Too many REMS cause headaches for doctors and the industry.

Manufacturing Compliance in the Spotlight

Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.
Aug 1, 2010

Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.

FDA Seeks Transparency in Data and Decisions

More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.
Jul 1, 2010

More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.

Manufacturers, FDA Seek to Secure Supply Chains

International outsourcing and rising theft spur regulatory action and manufacturer oversight.
Jun 1, 2010

International outsourcing and rising theft spur regulatory action and manufacturer oversight.

Healthcare Reform Expands Coverage, Promotes Innovation

Broader benefits and biosimilars will offset hefty fees and discounts while preserving R&D incentives.
May 1, 2010

Broader benefits and biosimilars will offset hefty fees and discounts while preserving R&D incentives.

REMS Raise Concerns for Biotech Products

The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.
Apr 1, 2010

The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.

Pharma Cheers Health Reform Legislation

Mar 22, 2010

After months of increasingly rancorous debate, the House finally approved legislation March 21 that makes significant changes in the nation?s healthcare system.

FDA Seeks More Timely Drug Information Electronically

The new Sentinel system aims to expand access to data on medical product safety and patient effects.
Mar 1, 2010

The new Sentinel system aims to expand access to data on medical product safety and patient effects.

Biotech Manufacturing Under Scrutiny

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.
Feb 1, 2010

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

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