The U.S. Food and Drug Administration (FDA) issues a final rule amending its “postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive.” Effective June 10, 2014, the rule is intended to help the agency “more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information.” FDA has also issued draft guidance titled “Providing Submissions in Electronic Format—Postmarketing Safety Reports,” to help those subject to the new rule comply with its requirements. Comments on the draft guidance are requested by August 11, 2014.
The U.S. Food and Drug Administration (FDA) issues a final rule listing those pathogens with the potential to pose a serious threat to public health, thus fulfilling a requirement of the Food and Drug Administration Safety and Innovation Act to “encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections.” As part of the mandate, FDA was required to consider including those “qualifying pathogens” posing a particular threat of drug resistance to humans.
The U.S. Food and Drug Administration (FDA) makes available draft industry guidance titled “Best Practices in Developing Proprietary Names for Drugs.” Among other matters, the draft “focuses on the safety aspects in the development and selection of proposed proprietary names for all prescription and nonprescription human drug products and biological products[,] . . . describes naming design practices to help avoid medication errors and provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review.” Written comments are requested by July 28, 2014.
The U.S. Food and Drug Administration (FDA) issues a final rule that implements its authority to detain drugs intended for human or animal use when “an authorized FDA representative conducting an inspection has reason to believe [they] are adulterated or misbranded.” Intended to “protect the public by preventing distribution or subsequent use of drugs encountered during inspections that are believed to be adulterated or misbranded, until FDA has had time to consider what action it should take concerning the drugs, and to initiate legal action, if appropriate,” the rule takes effect June 30, 2014.
The U.S. Patent and Trademark Office (USPTO) announces the June 30, 2014, opening of its permanent satellite office in Denver, Colorado.