Drugs
FDA has released the form FDA-483 issued following a 2/6-2/17 inspection at the Cipla sterile and non-sterile drug manufacturing facility in Madhya, Pradesh, India. The eight inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of
Drugs
U.S. Senators Maggie Hassan (D-NH) and Mike Braun (R-IN) have reintroduced their bipartisan bill to close a loophole that pharmaceutical companies can exploit to block drug competition, including generic drugs. The bill would restrict drug companies from patenting their Risk Evaluation and Mitigation Strategy (REMS) programs to
Drugs
The 2022 CDER Office of Generic Drugs (OGD) Annual Report outlines many highlights during the year, concurrent with the GDUFA 3 reauthorization. OGD approved or tentatively approved 914 ANDAs, participated in 108 pre-ANDA meeting requests, issued 257 product-specific guidances, issued 1,775 complete response letters detailing deficiencies before
Drugs
FDA has published a guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, describing the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). The document says it builds on existing International Council for Harmonization quality guidances to provide clarification on CM
Drugs
FDA has outlined new potential GMP issues under policy consideration in a discussion paper entitled “Artificial Intelligence (AI) in Drug Manufacturing.” The agency says difficulties could result from “potential ambiguity” on how to apply existing GMP regulations to AI or due to a lack of agency guidance or experience. The
Drugs
A jury has returned a $43 million verdict against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the False Claims Act and Anti-Kickback Statute. During the six-week jury trial, the United States proved that the defendants paid kickbacks to ophthalmic surgeons to induce their
Drugs
A 5/2-5/16/22 FDA inspection at the Skyless LLC drug manufacturing facility in Ponce, Puerto Rico, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A just-released 1/23 Warning Letter says specific CGMP violations were: * failing to have,
Drugs
FDA has published a draft guidance, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens, giving sponsors recommendations to assist in the development of monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of infection. The document
Drugs
CDER associate director for rare diseases Kerry Jo Lee says FDA is marking Rare Disease Day 2023 by exploring ways to engage and collaborate with patients, patient advocates, and other stakeholders to support the development of safe and effective therapies. Writing in an agency statement, Lee describes the Accelerate Rare
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
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
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
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.