Drugs
Federal Register notice: FDA is withdrawing approval of three NDAs from multiple applicants after they notified the agency that the products were no longer marketed and requested their withdrawal. The products are: * Bayer Healthcare’s Cipro in Dextrose 5% in plastic container (ciprofloxacin) Injectable, 200 mg/100 mL and 400
Drugs
FDA has approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Alexion’s Soliris (eculizumab) to treat specific rare diseases. An agency statement says Bkemv is approved for these Soliris indications: * treating patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis; and * treating patients with atypical hemolytic uremic
Drugs
Johnson & Johnson is reporting positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder with insomnia symptoms. Seltorexant is described as a first-in-class
Devices
The American Clinical Laboratory Association (ACLA), HealthTrackRX Indiana, and HealthTrackRX, Inc., are suing FDA in a Texas federal court to challenge the agency’s 5/6 final rule announcing its intent to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA). “Because
Drugs
FDA has granted Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. The therapy was also granted accelerated approval for advanced
Drugs
A CDER online post discusses the Center’s pharmaceutical quality function, saying it covers more than just a drug’s quality, including manufacturing facilities and the processes used to manufacture the drug. “Some of CDER’s pharmaceutical quality functions occur before a prescription drug is approved and reaches patients,” the
Devices
Medline Industries has recalled (Class 1) its Medline Sub-G Endotracheal Tube with Subglottic Suctioning after complaints were received about the device’s inflation tube detaching from the main tube. If a detachment occurs, this could result in potential moisture buildup, loss of pressure, or inability to inflate, recall notice
Devices
A bipartisan group of four senators and 11 members of the House is calling on FDA to strengthen protections for consumers with hearing loss by considering ways to inform them if they are purchasing so-called locked hearing aids. A letter to FDA commissioner Robert Califf says some hearing aid
Drugs
The International Council for Harmonization (ICH) has published the M12 final guideline on drug interaction studies. The document has recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction studies during the development of a therapeutic product. The
FDA Policy/General
Federal Register notice: FDA is seeking comments on an OMB information collection extension entitled “De Novo Classification Process (Evaluation of Automatic Class 3 Designation) — 21 CFR Part 860, Subpart D.” The collection supports agency regulations that establish a “De Novo” classification process and govern format and content elements for De
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of an emergency use authorization for Invivyd’s Pemgarda (pemivibart) for use as Covid-19 pre-exposure prophylaxis in certain adults and adolescents. Pemgarda is a recombinant monoclonal lgGh antibody that targets the Covid spike protein receptor binding domain, thereby inhibiting virus
Devices
FDA says Ostar Beauty Sci-Tech Co Ltd in Beijing Shi, China, is marketing several medical devices without marketing clearance or approval. A just-released 12/4/2023 Warning Letter identifies the three types of products that FDA says are adulterated because Ostar does not have an approved PMA or
Drugs
A 6/12-8/31/23 FDA inspection at Biomic Sciences, doing business as ION Intelligence of Nature in Charlottesville, VA, found several violations of the Federal Food, Drug, and Cosmetic Act. A just-released 5/9 Warning Letter lists violations involving adulterated human drugs, drug CGMP (current good manufacturing
Devices
FDA has cleared a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage. The device features a “Mimetix morphometric profile,” which was developed with digital models of the vertebrae to optimize the contact surface between implant and endplates, the company says. The system allows for fixation with
Drugs
Teva says an FDA recommendation for a unique manufacturing treatment for the cholesterol drug ezetimibe (Zetia) is inconsistent with the agency’s and other health authorities’ past regulatory treatment of the product and is “unwarranted.” The company’s analysis is in a comment letter for the FDA docket on a
Drugs
FDA has published for public comment the International Council for Harmonization M14 guidance, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines. The document recommends international standards for, and promotes harmonization of, the general principles on planning, designing, and
Biologics
FDA has accepted for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM). According to the company, if approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-
Devices
FDA is co-sponsoring with the Digital Medicine Society a 6/26-27 public workshop entitled “Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle.” The workshop is intended to illustrate how patient-generated health data (PGHD) can promote medical
Drugs
FDA has published a draft guidance, Platform Technology Designation Program for Drug Development, with details about the implementation of the platform technology designation program that was enacted as part of the 2023 Consolidated Appropriations Act. The agency says the document outlines eligibility factors for receiving a platform technology designation, how
FDA Policy/General
Federal Register notice: CDER is proposing to withdraw approval of four NDAs and is announcing an opportunity for the application holders to request a hearing on the proposal. The basis for the action is that the NDA holders have repeatedly failed to file required annual reports. The affected products are:
FDA Policy/General
Federal Register notice: FDA is issuing a priority review voucher to Pfizer after determining that its Paxlovid (nirmatrelvir co-packaged with ritonavir) tablets meet the criteria for a material threat medical countermeasure product application. The drug was approved 5/2023 for treating mild-to-moderate Covid-19. To view the
Drugs
Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) are calling on the Department of Justice (DoJ) to rescind its Office of Legal Counsel’s 2019 opinion on FDA jurisdiction over execution drugs and allow the agency to regulate the products. “The DoJ under the current Administration has reversed