Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

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.

Super Oversight for Generics

Dec 12, 2013

OGD is under pressure to improve review operations.

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.

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.

Congress Revises Rules for Drug Compounding and Supply-Chain Security

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
Nov 1, 2013

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

PhRMA Report Shows New Vaccine Development

Oct 4, 2013

PhRMA report reflects robust R&D in vaccine development.

FDA Seeks Metrics to Define Drug Quality

Manufacturing standards are considered key to preventing drug recalls and shortages.
Oct 1, 2013

Manufacturing standards are considered key to preventing drug recalls and shortages.

FDA Works to Secure Drug Supply Chain

New policies aim to strengthen inspection and oversight processes.
Sep 1, 2013

New FDA supply chain policies aim to strengthen inspection and oversight processes.

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