FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings. The document provides recommendations on cancer drug trials regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Covid– 19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention. The document primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial effectiveness evidence and adequate
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Zolgensma (onasemnogene abeparvovec-xioi), indicated for treating pediatric patients with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene. The regulatory review period is 2,088 days, which includes
FDA Policy/General
Rep. Diana DeGette (D-CO) says she and Rep. Fred Upton (R-MI) have drafted wording to be included in a circulating Cures 2.0 bill that would, among other things, create an Advanced Research Projects Agency for Health (ARPA-H) that is sought by President Joe Biden to develop
FDA Policy/General
Federal Register notice: FDA has announced a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs. The workshop is intended to discuss the challenges and clinical trial design considerations for developing such therapeutic products. To view the notice, click here.
FDA Policy/General
Retired FDA psychiatry products director Thomas Laughren has joined Cybin as a clinical advisory board member. The biotechnology company is focused on progressing psychedelic therapeutics, and it says Laughren is familiar with the potential challenges, and he brings extensive psychiatric regulatory and development expertise to its advisory board. Laughren retired
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. The document is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing,
FDA Policy/General
FDA says its review of a Web site and Amazon storefront maintained by Fresh Nutrition, Inc., Yorba Linda, CA, determined that the company is taking orders for several products that are legally considered to be drugs for use in diagnosing, curing, mitigating, treating, or preventing disease in humans and animals.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Daiichi Sankyo’s Turalio (pexidartinib), indicated for treating adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The regulatory review period is
FDA Policy/General
Former FDA chief counsel Stacy Cline Amin has joined Morrison & Foerster as a partner in its life sciences/healthcare practice. Amin resigned from FDA in January (see story) after almost two and a half years at the helm of the agency’s legal shop. Prior to FDA, she served
FDA Policy/General
Federal Register notice: FDA has announced for administrative purposes the issuance of an emergency use authorization to B. Braun Melsungen AG and the use of its sedative propofol-lipuro 1% injectable emulsion in Covid-19 patients requiring mechanical ventilation. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals’ Givlaari (givosiran), indicated for treating adults with acute hepatic porphyria. The regulatory review period is 1,533 days, which includes 1,363 days that occurred during the testing phase and 170 days during
FDA Policy/General
Guide on Premenopausal Women with Breast Cancer 6/17/2021 Federal Register notice: FDA has made available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. The document provides recommendations about including premenopausal women in breast cancer clinical trials. To view the notice, click here. Progressive
FDA Policy/General
FDA’s controversial decision to provide accelerated approval to Biogen’s Alzheimer’s drug illustrates the need to disrupt the status quo at FDA and nominate someone other than acting commissioner Janet Woodcock, Senator Joe Manchin (D-WV) said in a 6/17 letter to President Biden. Noting the scientific
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. The document provides recommendations about including premenopausal women in breast cancer clinical trials. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/21 public workshop entitled “Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs.” The workshop is intended to discuss the challenges and clinical trial design considerations for developing therapeutic products for treating progressive multifocal leukoencephalopathy. To view the notice, click here.
FDA Policy/General
FDA has accepted an AcelRx proposed plan to update certain promotional materials for its Dsuvia (sufentanil sublingual tablet, 30 mcg) in response to an agency 2/11 Warning Letter. The Warning Letter said a banner and tabletop display made false or misleading claims and representations about the drug’s risks
FDA Policy/General
HHS secretary Xavier Becerra says there is no immediate rush to nominate an FDA commissioner and that the agency is fortunate to currently have acting commissioner Janet Woodocock at the helm. In a 6/16 interview with Bloomberg news, Becerra had this to say about the unfilled agency post: “So
FDA Policy/General
The Government Accountability Office (GAO) says its study of direct-to-consumer (DTC) drug advertising and Medicare spending on advertised drugs found it is hard to isolate the relationship between drug advertising, use, and spending. The report looked at drug manufacturer spending on DTC, Medicare spending on advertised drugs, and
FDA Policy/General
Federal Register notice: FDA is seeking comments on the use of study data exchange standards from stakeholders involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications, abbreviated new animal drug applications, or applications for conditional
FDA Policy/General
Federal Register notice: FDA has announced that it received a petition requesting exemption from the premarket notification requirements for the generic device type: “powered patient transport, all other powered patient transport.” The products are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a
FDA Policy/General
Federal Register notice: FDA is correcting a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants. That notice indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the notice was published with an incorrect application number for