Dosage Forms

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

Generic Drug Battles Heat Up

Novartis to Expand Generics Business

Generic Drug for HIV/AIDS Gains FDA's Tentative Approval

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.

The Push for Generics Challenges Manufacturers

Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.

Generic Drugs