FDA Policy/General
Federal Register notice: Health and Human Services is proposing to withdraw or repeal a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/22. However, on 3/9 a lawsuit was filed seeking
FDA Policy/General
Federal Register notice: FDA has announced a periodic listing of Emergency Use Authorizations (EUAs) for certain medical devices related to the Covid–19 public health emergency. The EUAs contain, among other things, conditions on the emergency use of the authorized products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Infant Formula Requirements * Shortages Data Collection * Guidance on Labeling for Natural Rubber Latex Condoms * Section 513(g) Requests for Information To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified rare pediatric disease product application. The agency determined that the company’s Rethymic (allogeneic processed thymus tissue-agdc), indicated for immune reconstitution in pediatric patients with congenital athymia, meets
FDA Policy/General
FDA says the CDER Office of Prescription Drug Promotion is proposing to investigate the influence of targeted mechanism of action claims, graphics, and disclosures that provide context about a drug’s targeted mechanism of action in both consumer and healthcare professional promotions. A Federal Register notice says the research will
FDA Policy/General
Federal Register notice: FDA has announced the revocation of the Emergency Use Authorization issued to Life Technologies Corporation for the TaqPath CovidD–19 MS2 Combo Kit 2.0, an in vitro diagnostic device for detecting Covid–19. FDA revoked the EUA at the company’s request because it is no
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Nabriva Therapeutics’ Xenleta injection (lefamulin), indicated for treating adults with community-acquired bacterial pneumonia caused by susceptible microorganisms. The review period is 3,595 days, which includes 3,351 days that occurred during the testing
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Impact Biomedicines’ Inrebic (fedratinib), indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. The review period is 4,285 days,
FDA Policy/General
The FDA Office of Minority Health and Health Equity has awarded the Yale School of Medicine a $3 million contract to promote clinical trial education, awareness, and access for underrepresented minorities. A Yale statement says the medical school made great strides in that area during the height of the Covid-
FDA Policy/General
Federal Register notice: FDA has announced an 11/30 Antimicrobial Drugs Advisory Committee meeting to review a Merck Emergency Use Authorization request for molnupiravir oral capsules, indicated for treating mild to moderate Covid-19 in adults who are at risk for progressing to severe disease or hospitalization. To view the
FDA Policy/General
Federal Register notice: FDA is announcing the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2022. In addition, FDA has established a docket where interested persons may comment on topic priorities. To view the notice, click here.
FDA Policy/General
Federal Register proposed order: FDA is proposing to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act as amended by the Coronavirus Aid, Relief, and Economic Security Act. Under the proposal, the following two categories of biological products would be exempt
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution — 21 CFR Part 207” (OMB Control Number 0910-0045). The collection was revised to include the collection of certain information required by the Coronavirus Aid,
FDA Policy/General
Federal Register notice: FDA has announced a 12/10 meeting of the Medical Devices Advisory Committee’s Neurological Devices Panel. Members are scheduled to vote on a BrainsGate PMA for its Ischemic Stroke System, indicated for increasing cerebral blood flow and to reduce disability in adult patients with acute ischemic
FDA Policy/General
FDA Withdraws Approval for 216 ANDAs 10/22/2021 Federal Register notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw
FDA Policy/General
Alexion Pharmaceuticals has agreed to acquire Wilson Therapeutics and investigational drug WTX101 (bis-choline tetrathiomolybdate) for treating Wilson disease. The first-in-class copper-binding agent with a unique mechanism of action is designed to detoxify excess copper in both liver and blood, and promotes copper clearance through biliary excretion.
FDA Policy/General
BIOLOGICS FDA has approved Hospira’s Inflectra (infliximab-dyyb), a biosimilar product referencing Janssen Biotech’s Remicade. The approval covers indications such as: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. The document provides recommendations to sponsors when submitting study data derived from real-world data sources in applicable regulatory submissions using standards specified in the Data Standards
FDA Policy/General
Federal Register notice: FDA has determined that 20 listed drug products were not withdrawn from sale due to safety or effectiveness issues. The determination means that FDA will continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice,
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw approval, and the holders of the 216 applications did
FDA Policy/General
Former Obama Administration FDA commissioner and current frontrunner for the nomination Robert Califf seemed on the brink of being announced as President Biden’s choice 2/22 when he visited the White House. According to a Politico report, the White House has spent the last few weeks vetting Califf, who
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Orion Corp.’s Nubeqa (darolutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,576 days, which includes 2,420 days that occurred during the testing phase