FDA Policy/General
A lengthy Bloomberg Law report says a review of FDA records shows the agency is doing little to cut down on misleading drug claims on social media, despite having released draft social media guidelines in 2004. The report says that since issuing the draft guidance, the agency has “done little
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Advanced Manufacturing Technologies Designation Program.” The document encourages the early adoption of advanced manufacturing technologies (AMTs) that can benefit patients by improving manufacturing and supply dependability and optimizing product development times. It says AMTs can directly improve product quality
FDA Policy/General
Federal Register notice: FDA is establishing the Genetic Metabolic Diseases Advisory Committee, and its duration is two years from the date the charter is filed. The committee can be renewed if the agency determines that it is in the public interest. The nine-voting-member panel is intended to review
FDA Policy/General
HHS has opened its review of FDA’s efforts to create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. An agency statement says the proposed reorganization would strengthen its ability to oversee and protect the human food supply and other products it regulates. New
FDA Policy/General
Nine Republican senators are urging FDA to increase its foreign inspections of medical product manufacturing facilities. In a 12/13 letter to FDA commissioner Robert Califf, the lawmakers cite the agency’s own data and ask why it completed “only eight inspections of Chinese drug manufacturers and zero of Chinese
FDA Policy/General
Federal Register notice: FDA is making available a summary of the comments received for the “Methodological Challenges Related to Patient Experience Data; Request for Information and Comments” notice published 5/2. on May 2, 2023. The input received is intended to help FDA plan two public workshops focused on methodological
FDA Policy/General
Federal Register notice: CDER and CBER are announcing that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model version 3.4 of the CDISC Study Data Tabulation Model Implementation Guide, and version 1.0 of the Standard for Exchange of Nonclinical
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Peloton Therapeutics Welireg (belzutifan), indicated for treating adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors. The regulatory review period is
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Bayer’s Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five related ANDAs that referenced the NDA. The actions are based on the agency’s determination that the products’ effectiveness for treating acute uncomplicated cystitis is not supported by the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Time and Extent Applications (TEA) for Nonprescription Drug Products.” The agency says the Coronavirus Aid, Relief, and Economic Security Act included provisions on the way certain OTC drugs are regulated, such as adding section 505G to the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with provisions in the Drug Supply Chain
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for QED Therapeutics’ Truseltiq (infigratinib), indicated for treating adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications, abbreviated new animal drug applications, and conditionally approved new animal drug applications during July, August, and September. The regulations are also being amended to improve their accuracy and readability. To
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821.” The collection supports the agency’s authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical device, if the device
FDA Policy/General
Federal Register notice: FDA is announcing that it has issued a priority review voucher to Genzyme after gaining a qualified approval for Xenpozyme (olipudase alfa-rpcp), indicated for treating non-central nervous system manifestations of acid sphingomyelinase deficiency. The voucher was awarded under the agency’s voucher program for rare
FDA Policy/General
Federal Register notice: FDA has announced that CBER has modified organizational structures in the Office of Blood Research and Review (OBRR) and the Office of Vaccines Research and Review (OVRR). The organization structures were approved by HHS 6/27. In OBRR, the Center established the Laboratory of Pathogen Reduction to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Associated Fees Under Section 744K.” The collection supports the annual registration of such facilities
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Orphan Drugs — 21 CFR Part 316.” The collection supports FDA regulations covering such products, such as recommendations on studies required for a product’s approval. It also supports the conditions under which a sponsor of an approved
FDA Policy/General
FDA chief scientist Namandjé Bumpus has been selected to replace principal deputy commissioner Janet Woodcock when she retires early next year. In an online “X” announcement, FDA commissioner Robert Califf called Bumpus a “powerhouse scientist and leader, who will continue to advance the agency’s critical public health initiatives using
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Product Jurisdiction and Combination Products — 21 CFR Parts 3 and 4.” The collection supports FDA’s authority to assign combination products to the appropriate agency component for regulation. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is proposing to classify into Class 3 certain types of wound dressings and liquid wound washes containing antimicrobials or other chemicals as solid wound dressings, and wound dressings formulated as a gel, cream, or ointment. The agency currently regulates the unclassified devices as those devices requiring
FDA Policy/General
Sens. Dick Durbin (D-IL) and Charles Grassley (R-IA) asked the Senate on 11/28 for unanimous consent to pass their bipartisan Drug-price Transparency for Consumers (DTC) Act that would require list price disclosures in ads for prescription drugs. A statement from Durbin says Sen. Mike Crapo (R-