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Government regulations and private market incentives in the new Medicare prescription drug law could boost generic drug prescription volumes by an additional 15 percent, according to federal officials and private-sector healthcare executives.
Drug leakage from the edges of its transdermal patches has prompted Janssen Pharmaceuticals to issue a Class I recall on its Duragesic (fentanyl transdermal system) patches, the firm reported Feb. 17.
An estimated 3,995 packaging lines at 1,447 facilities nationwide will be expected to affix linear bar codes to the labels of their prescription drug products used in hospitals under a new FDA final rule that could cost industry participants more than $28 million in compliance costs during the first two years of implementation.
Washington, D.C.-based law firm Hogan & Hartson has joined a growing number of petitioners urging the FDA to allow over-the-counter (OTC) hearing aid sales.
Critics of the FDA’s proposed rule on in vivo bioequivalence (BE) data are wondering whether the agency can find the additional time and personnel needed to comprehensively review drugmakers’ BE data submitted in abbreviated new drug applications (ANDAs).