Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

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.

Regulatory Roundup

Sep 1, 2013

Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.

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.

Generic Drugs Face Regulatory and Scientific Challenges

FDA funds research to further development of innovative generics, while working to address review and approval issues.
Aug 1, 2013

FDA funds research to further development of innovative generics, while working to address review and approval issues.

FDA Urges Greater Focus on Contractor Quality

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
Jul 1, 2013

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

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