Jill Wechsler

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

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.

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 stiffer FDA regulation of these activities.

The heavy buzz at the recent fall technical conference sponsored by the Generic Pharmaceutical Association (GPhA) involved proposals for reorganizing the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER).

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.

Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA).

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

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

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

Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic.

Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic.

A Q&A with FDA Deputy Commissioner Deborah Autor.

In a 5–4 vote, the Supreme Court has ruled in favor of the Constitutionality of the Affordable Care Act.

The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the U.S. health care system.

Legislation fails to establish national track-and-trace system, but tackles shortages.

House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support FDA regulatory programs.

Are pharmaceutical manufacturers really serious about ensuring the quality of their medicines? And do they recognize that cutting corners on controls and quality management can be tremendously costly in the long run?

New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure.

Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.

Soaring opioid use creates challenges for new drug development and supply-chain control.

Social media use raises questions about applying old standards to new information technology.

After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.

Manufacturers fund research and reduce prices to tackle diseases.

PDUFA renewal legislation sets stage for new policies affecting revenue, resarch, and oversight.

Rising imports and overseas production spur realignment of enforcement.