Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

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.

Issues and Opportunities Challenge Biotech Manufacturers

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.
Jan 1, 2010

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

The Promise and Perils of Vaccines

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.
Dec 1, 2009

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

Safety First in Biotech Development

Heightened attention to product safety issues is slowing the approval process for new therapies.
Nov 1, 2009

Heightened attention to product safety issues is slowing the approval process for new therapies.

FDA Leaders Stress Science and Compliance

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.
Oct 1, 2009

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

Biopharmaceutical Manufacturers Seize Opportunities in the Global Health Arena

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.
Sep 1, 2009

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.

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