Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

Global Expansion Shapes Drug Oversight

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Jun 1, 2014

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Demand for New Vaccines Spurs Innovation

New formulations and expanded vaccine production are encouraged.
May 1, 2014

New formulations and expanded vaccine production are encouraged.

FDA and Manufacturers Seek a More Secure Drug Supply Chain

New identifiers and tracking requirements aim to block illegitimate products.
Apr 1, 2014

New identifiers and tracking requirements aim to block illegitimate products.

Manufacturers Struggle with Breakthrough Drug Development

Accelerated testing and production create challenges in documenting product quality.
Mar 1, 2014

Accelerated testing and production create challenges in documenting product quality.

FDA Outlines Agenda for New Guidances in 2014

Feb 5, 2014

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

Metrics Sought to Ensure Drug Quality

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
Jan 1, 2014

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

Analyzing Nano Drugs

Dec 12, 2013

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

Super Oversight for Generics

Dec 12, 2013

OGD is under pressure to improve review operations.

Opioid Regulation Challenges FDA and Manufacturers

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
Dec 1, 2013

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

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