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CDRH Turnover and Consistency Top Questions at RAPS

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Staff turnover and consistency concerns top the questions on the minds of industry after a CDRH executive briefing during the Regu...

FDA Corrects Error in Blood Products Rule

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Federal Register Proposed rule: FDA corrects typographical errors on an 8/16 Federal Register proposed rule that updates regulatio...

DTC Restrictions Beaten Back

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Advertising and media companies work with drug companies to eliminate the most onerous DTC restrictions from FDA reform legislatio...

CGMP Problems at Chinese Drug Company

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FDA warns Chinas Kunshan Chemical and Pharmaceutical Company about CGMP violations at its API manufacturing facilities.

OMB OKs Info on Pharma Development Study

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on pharmaceutical developme...

Comments Sought on Radioactive Drugs Regs

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Federal Register Notice: FDA seeks comments on regulations governing the use of radioactive drugs for basic informational research...

Public Meeting on IT Resources in Reviewing NDAs

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Federal Register Notice: FDA plans a public meeting 10/19 to discuss applying information technology resources to support the revi...

Cephalon Submits Treanda NDA

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Cephalon submits an NDA to FDA for Treanda for treating patients with chronic lymphocytic leukemia.

FDA OKs Novo Nordisk NDA for Turner Syndrome

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FDA approves a Novo Nordisk NDA for Norditropin for treating children with short stature associated with Turner syndrome.

Von Eschenbach on FDA Values and Vision

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An all-hands Webcast by FDA commissioner Andrew von Eschenbach attempts to rally the troops as the agency begins to plan for new a...