Devices
With the 10/1 deadline for the required use of FDA’s electronic Submission Template and Resource (eSTAR) templates for 510(k) submissions approaching, Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says there is a bit of a learning curve in determining a good process for
Biologics
CBER’s Office of Therapeutic Products has announced a 4/27 public listening meeting to receive input on methods and approaches (e.g., real-world evidence (RWE), registries) for capturing post-approval safety and efficacy data for cell and gene therapy products. “With an increasing number of cell and gene
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 3/1 voted 10 to 2 and 12 to 0, respectively, that safety data and effectiveness data were adequate to support approval of GSK’s vaccine Arexvy (RSVPreF3-AS01E) for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV)
Devices
An FDA letter to healthcare professionals is warning about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The blood oxygenation and carbon dioxide removal system is used to pump blood through the extracorporeal bypass circuit for either circulatory support, pulmonary support, or both, for
Drugs
FDA has issued Cytokinetics a complete response letter on its NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating heart failure with reduced ejection fraction (HFrEF). “FDA communicated that [the Phase 3 GALACTIC-HF study] is not sufficiently persuasive to establish substantial evidence of effectiveness
Drugs
CBER issued four new Standard Operating Policy and Procedure (SOPP) documents on 2/27: SOPP 8421: Complying with Requirements Under the Pediatric Research Equity Act (PREA) is a first-line resource for product offices and review divisions to ensure that sponsors/applicants and CBER staff are following the required procedures
FDA Policy/General
FDA issued a 2/28 Import Alert intended to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the U.S. to address what it says is a growing public health concern. An agency statement says xylazine has increasingly been found in illicit
Drugs
FDA and the Federal Trade Commission (FTC) have released a summary of their 3/9/2020 joint workshop on a competitive marketplace for biosimilars. The document says the workshop’s purpose was to “discuss FDA’s and FTC’s collaborative efforts to support appropriate adoption of biosimilar products, discourage false
FDA Policy/General
FDA commissioner Robert Califf says his vision in revamping the agency’s human foods program and the Office of Regulatory Affairs (ORA) “is focused on a new agency-wide model where the activities and responsibilities of the regulatory programs and ORA are better synced to improve efficiency and effectiveness with
Drugs
Universities Allied for Essential Medicines (UAEM) North America is petitioning FDA for increased enforcement of the ClinicalTrials.gov reporting requirements under the FDA Amendments Act (FDAAA) of 2007. The petition, prepared and submitted by Columbia Law School’s Morningside Heights Legal Services, specifically asks that the agency: * increase enforcement of
Drugs
FDA has sent Gascó Industrial Corp. in Gurabo, Puerto Rico, a Warning Letter after inspecting its manufacturing facility and citing significant GMP violations. For example, the 2/17 letter said the company failed to maintain adequate separate defined areas necessary to prevent contamination or mix-ups. The inspection also found
Drugs
Merck says it is discontinuing the Phase 3 KEYNOTE-641 trial evaluating Keytruda (pembrolizumab) in combination with enzalutamide and androgen deprivation therapy (ADT) for treating patients with metastatic castration-resistant prostate cancer, based on the recommendation of an independent data monitoring committee. An interim analysis found that the combination therapy
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee 2/28 voted (7 to 4) that Pfizer’s BLA data are adequate to support approval of respiratory syncytial virus bivalent vaccine RSVpreF (PF-06928316). The vaccine is being reviewed by FDA for preventing acute respiratory disease and lower respiratory tract
Drugs
FDA is seeking comments on a just-released discussion paper on artificial intelligence (AI) areas for use in drug manufacturing and policy development associated with such use. The paper is based on issues raised in a 2021 National Academies of Sciences, Engineering, and Medicine report titled “Innovation in Pharmaceutical Manufacturing
Drugs
FDA has approved a Reata Pharmaceuticals NDA for Skyclarys (omaveloxolone) as the first treatment for Friedreich’s ataxia, a rare degenerative disease that damages the nervous system. The disease, which is characterized by impaired coordination and walking, causes progressive damage to the spinal cord, peripheral nerves, and the brain, resulting
Drugs
A top figure in FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm is retiring from CDER’s Office of Neuroscience (ON) — director Billy Dunn. After an 18-year career at the agency, Dunn has decided to “explore other opportunities while continuing his focus on improving the lives
Devices
FDA has issued a letter to healthcare providers warning about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta heart valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets mounted to the valve frame. “Information from published literature suggests
Biologics
FDA has proposed that Pfizer include Guillain-Barré syndrome (GBS) and other immune-mediated demyelinating conditions in a pharmacovigilance plan (PVP) if the company’s BLA for Abrysvo (RSVpreF) is approved. The company is seeking an indication for preventing acute respiratory disease and lower respiratory tract disease caused by Respiratory
Drugs
FDA has accepted for review a Verrica Pharmaceuticals NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Control as an infection caused by a virus. The result of the infection is usually a benign, mild skin disease characterized by lesions that may appear anywhere
Drugs
FDA has issued a five-year debarment order against former Indivior CEO Shaun Thaxter based on an earlier misdemeanor conviction. In 2020, the Western Virginia District Court sentenced Thaxter to six months in federal prison after he pleaded guilty to a charge of introducing into interstate commerce misbranded shipments of
Drugs
FDA has accepted for priority review a SpringWorks Therapeutics NDA for nirogacestat, an investigational gamma secretase inhibitor for treating adults with desmoid tumors. The agency has set an 8/27 user fee review action target date. The NDA is based on previously announced data from the Phase 3 DeFi trial.
Drugs
Washington attorney general Bob Ferguson and Oregon attorney general Ellen Rosenblum are leading a multistate lawsuit against FDA accusing it of singling out one (mifepristone) of the two drugs used for medication abortions through “excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol,” the officials announced