Regulatory Roundup: Guidance Issued for Formal Dispute Resolution, More...

The US Food and Drug Administration announced in the Aug. 31, 2009 Federal Register that the Office of Management and Budget (OMB) approved the Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level under the Paperwork Reduction Act of 1995. The guidance’s proposed collection of information was submitted to OMB in April for approval because valid OMB control numbers are required for a collection of information. The approval expires on Aug. 31, 2012.

FDA issued several enforcement letters during the past two weeks. Cambrex (East Rutherford, NJ) received a Warning Letter relating to an inspection of the company's generic active pharmaceutical ingredient manufacturing facility in Milan, Italy, in March 2009, according to a company release. The observations are primarily related to the collection and maintenance of certain laboratory data, and Cambrex has addressed several of the FDA observations already, according to the release. FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a letter to Johnson & Johnson (Skillman, NJ) regarding a journal advertisement for its Ertaczo (sertaconazole) cream. The ad “broadens the approved indication, contains unsubstantiated efficacy claims about the product, and omits important risk information,” according to the letter. DDMAC also sent a letter to Pedinol Pharmacal (Farmingdale, NY) regarding a professional direct mailer for Nalfon (fenoprofen calcium). According to the letter, the mailer contains false or misleading information about the product.