Articles by Jill Wechsler - Pharmaceutical Technology

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Articles by Jill Wechsler

Manufacturers Struggle with Breakthrough Drug Development

Accelerated testing and production create challenges in documenting product quality.
Mar 2, 2014

Accelerated testing and production create challenges in documenting product quality.

FDA Focuses on Drug Appearance and Attributes

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.
Feb 2, 2014

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

Metrics Sought to Ensure Drug Quality

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
Jan 2, 2014

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

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.

Super Oversight for Generics

Dec 12, 2013

OGD is under pressure to improve review operations.

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.
Dec 4, 2013

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

Opioid Regulation Challenges FDA and Manufacturers

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
Dec 2, 2013

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

FDA Seeks Metrics to Define Drug Quality

Manufacturing standards are considered key to preventing drug recalls and shortages.
Nov 13, 2013

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

Generic Drug Super Office Takes Shape

Nov 8, 2013

Generic Drug Super Office Takes Shape

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
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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