Dosage Forms

Robert Lionberger is a chemist at the Office of Generic Drugs at the US Food and Drug Administration.

Gordon Johnston is vice-president of regulatory sciences at the Generic Pharmaceutical Assocation.

Lawrence X. Yu is deputy director for science in the Office of Generic Drugs (OGD) at the US Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.

Gary Buehler is director of the Office of Generic Drugs at the US Food and Drug Administration.

Michael C. Olson is a chemist at the Office of Pharmaceutical Science at FDA.

Helen Winkle is director of the Office of Pharmaceutical Science.

Articles

The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives.

Quality by Design for Generic Drugs

Jim Greenwood is president and CEO of the Biotechnology Innovation Organization (BIO). He represented Pennsylvania’s 8thÂ district in the US House of Representatives from 1993 to 2005.

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.

Progress Made on the Path to Biosimilars

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in August 2009.

Controlled-release formulations targeted by generic companies

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.

Controlled-Release Formulations a Popular Strategy for Generic-Drug Companies

The author reviews the major biopharmaceutical markets' activity and predicts how the markets may evolve.

Market Outlook for Biosimilars

Angie Drakulich was editorial director of Pharmaceutical Technology.

Two years ago, the US Food and Drug Administration's Office of Generic Drugs (OGD) developed and implemented a program to test question-based reviews for abbreviated new drug applications (ANDAs). OGD is reviewing the benefits and challenges faced by pharmaceutical firms involved in the initiative to see what changes need to be made going forward.

FDA's Dr. Srinivasan Discusses Question-based Reviews for Generic Drugs

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The Federal Trade Commission (FTC) last week issued an interim report that examined the effects of authorized generics on competition in the prescription drug market.

FTC Issues Report on Authorized Generics

The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology.

FDA Office of Generic Drugs Question-Based Review Initiative: An Update

Follow-on biologics or biosimilars offer a niche growth market for the pharmaceutical industry. As the process for establishing a regulatory pathway for biosimilars is debated, companies, including Big Pharma, are positioning themselves to gain this piece of the pharmaceutical pie.

Gauging Opportunities in the Biosimilars Market

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