Articles by Jill Wechsler - Pharmaceutical Technology

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Articles by Jill Wechsler

GMP Compliance Becomes Prominent Enforcement Issue

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.
Feb 2, 2013

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.

Drug Quality at Center Stage for FDA and Manufacturers

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.
Jan 1, 2013

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

Health Policy Challenges for Obama Administration

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.
Dec 2, 2012

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

Product Analysis Key to Biosimilar Development

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
Nov 2, 2012

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

Meningitis Outbreak Linked to Contaminated Vials of Steroid Injectables

Oct 9, 2012

A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stronger FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention reported seven deaths and 91 ill.

New Era for Generic Drugs

User fees aim to speed approvals and support timely plant inspections.
Oct 2, 2012

The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.

Campaign Mounts to Curb Counterfeit Drugs

Import controls and risk strategies aim to promote quality and spur new drug development.
Sep 2, 2012

Import controls and risk strategies aim to promote quality and spur new drug development.

Healthcare Reform is Given the Go-Ahead: Now What?

No matter the upside or downside to the Affordable Care Act, there's work to be done.
Aug 2, 2012

No matter the upside or downside to the Affordable Care Act, there's work to be done.

FDA User-Fee Legislation Sets Stage for Change

Import controls and risk strategies aim to promote quality and spur new drug development.
Aug 2, 2012

Import controls and risk strategies aim to promote quality and spur new drug development.

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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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