Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

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.

GMP Compliance Becomes Prominent Enforcement Issue

Shortages spur efforts to overhaul manufacturing oversight.
Feb 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

Drug Quality at Center Stage for FDA and Manufacturers

Shortages spur efforts to overhaul manufacturing oversight.
Jan 1, 2013

Shortages spur efforts to overhaul manufacturing oversight.

Research Policies Pose New Challenge for US Administration

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.
Dec 1, 2012

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

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