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Industry trade group giants, PhRMA and BIO are nudging FDA to re-examine how it regulates off-label communication between drugmakers, health-care providers and payers. Read More
Mylan has agreed to shed two generics that treat muscle pain and epilepsy to allay FTC antitrust concerns, clearing the way for its $7.2 billion acquisition of Meda. Read More
The EMA is advising drugmakers to rely on two types of analyses — metabolic and mechanism of action — to determine the minimum effective dosage for antimicrobial drugs. Read More
An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year. Read More