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U.S. Pharmacopeia's (USP) recent decision to exclude a new Medicare Part D drug policy requiring broader coverage in its revised formulary guidelines makes it easier for the government to drop this policy and may necessitate a legislative fix, according to
a key Senate staffer.
The HHS Office of Inspector General (OIG) continues to investigate the circumstances surrounding the resignation of former FDA commissioner Lester Crawford, according to a recent correspondence from the OIG to lawmakers.
The HHS Office of Inspector General (OIG) continues to investigate the circumstances surrounding the resignation of former FDA commissioner Lester Crawford, according to a recent correspondence from the OIG to lawmakers.
The HHS Office of Inspector General (OIG) continues to investigate the circumstances surrounding the resignation of former FDA commissioner Lester Crawford, according to a recent correspondence from the OIG to lawmakers.
The HHS’s Office of Inspector General (OIG) plans to examine adverse events reporting for medical devices and review the FDA’s process for addressing deficiencies in foreign device manufacturing facilities, according to the OIG’s fiscal 2006 work plan.
Companies that do not prepare sufficiently for the upcoming competitive drug-purchasing program under Medicare Part B could find themselves losing customers and possibly even violating federal law, according to an industry attorney.
Companies that do not prepare sufficiently for the upcoming competitive drug-purchasing program under Medicare Part B could find themselves losing customers and possibly even violating federal law, according to an industry attorney.
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) lauded a recent draft guidance on adverse event reporting at its recent meeting in Washington, D.C. SACHRP also grilled the FDA about when it could expect similar guidance from the agency.
U.S.-based generic firms Mylan Laboratories and Barr Laboratories have a leg up in the race to win a sublicense for Roche’s highly sought-after antiviral Tamiflu, according to a Nov. 21 Banc of America Securities report
A group of House Democrats has sent a letter to HHS Secretary Michael Leavitt demanding an explanation of former FDA commissioner Mark McClellan’s role in the agency’s controversial handling of Barr Laboratories’ emergency contraceptive Plan B.