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ePT--the Electronic Newsletter of Pharmaceutical Technology

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

ePT--the Electronic Newsletter of Pharmaceutical Technology

President-elect Barack Obama officially nominated former Senator Tom Daschle as Secretary of Health and Human Services and named him the Director of a new White House Office on Health Care Reform late last week.

ePT--the Electronic Newsletter of Pharmaceutical Technology

At its annual business briefing held last week, Merck & Co. outlined its short- and long-term strategy for growth. Its strategy is focused on increased penetration in emerging markets, the establishment of a business for developing follow-on biologics or biosimilars, and a new commercial model for product life-cycle management.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.

The Blame Game

When accusations fly: 'Tis better to give than to receive.

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Report From: India

While the world pulls itself out from one of the worst crises in decades, Indian pharmaceutical companies are trying to capitalize on falling company prices by increasing their takeovers.