Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

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.

Regulatory Roundup

Sep 1, 2013

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

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.

Congress Considers Legislation to Secure Drug Supply Chain

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
Jun 1, 2013

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

Regulatory Convergence Sought for Global Pharma Market

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
May 1, 2013

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

Manufacturers Under Pressure to Manage Painkillers

Opioid abuse generates calls for efforts to curb distribution.
Apr 1, 2013

Opioid abuse generates calls for efforts to curb distribution.

Vaccine Innovation Yields New Products and Processes

Vaccine development is benefiting from manufacturing advances.
Mar 1, 2013

Vaccine development is benefiting from manufacturing advances.

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