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Guidances on the clinical evaluation or approval requirements for six classes of drugs were withdrawn last week because they are out of date and of little value to the industry, according to the FDA.
The FDA has announced a new standard format that sponsors can use to submit data to the agency regarding human drug clinical trials — a format the agency hopes will lead to greater efficiencies in clinical research and FDA reviews of new drug applications.
The FDA is withdrawing six guidances on the clinical evaluation or approval requirements for six classes of drugs because they are out of date and of little value to the industry, the agency announced yesterday.
The Senate has approved a free trade agreement (FTA) between the U.S. and Australia that includes a provision that grants patent holders — including the holders of pharmaceutical patents — the right to block importation of a patented product into the U.S.
Three popular Rx drugs purchased from a website advertised as Canadian revealed the products to be potentially dangerous, according to the FDA, which analysized the purported generic versions of the drugs.
The FDA is on track to approve more new molecular entities (NMEs) this year than it did last year. For the first six months of 2004, the FDA approved 12 NMEs, compared to only seven for the comparable period in 2003 and 17 NMEs for all of 2002.
A new study has found that despite extensive efforts by the government and the AARP, support among Medicare beneficiaries for the new prescription drug program is flagging.
A joint FDA advisory committee said it could not approve Allergan’s oral retinoid treatment for psoriasis because even though the treatment demonstrated modest efficacy in pivotal trials, the accompanying risk management program is inadequate.
A District of Columbia federal court has refused King Pharmaceuticals’ request to revoke FDA approval of supplemental new drug applications (sNDAs) that propose to establish bioequivalence between King’s thyroid product Levoxyl and two other products: Jerome Stevens’ Unithroid and Mova Pharmaceutical’s Levo-T.
Industry group says that even though the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way in establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs.