Drugs
FDA is requesting that all bacitracin for injection manufacturers voluntarily withdraw their product from the market because the benefits no longer outweigh safety concerns. Bacitracin for injection is currently approved for treating infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs)
Drugs
FDA has approved a Teva Pharmaceuticals autoinjector device for its Ajovy (fremanezumab-vfrm) injection for preventing migraine in adults. Previously, the calcitonin gene-related peptide antagonist was approved for administration in a pre-filled syringe. Teva says that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with
Drugs
FDA has granted Aprea Therapeutics a breakthrough therapy designation for APR-246 in combination with azacitidine for treating myelodysplastic syndromes (MDS) with a susceptible TP53 mutation. MDS is a hematopoietic stem cell malignancy where bone marrow fails to produce healthy blood cells, the company says. About 30-40% of MDS
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Gene Therapy for Hemophilia; Guidance for Industry.” The document provides recommendations on the clinical trial design and related development for coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in activity
Drugs
Public Citizen has filed suit against FDA in DC federal court to obtain the scientific reviews used 4/2019 to grant accelerated approval for Janssen Pharmaceutical’s Balversa (erdafitinib), a treatment for certain adult patients with locally advanced or metastatic bladder cancer (see approval story). The group filed a Freedom
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.” The document provides FDA’s current thinking on the criteria to determine sameness of human gene therapy products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled “Human Gene Therapy for Retinal Disorders; Guidance for Industry.” The document provides recommendations to stakeholders about product development, preclinical testing, and clinical trial design for such products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Gene Therapy for Rare Diseases; Guidance for Industry.” The document provides information to assist sponsors in designing clinical development programs for such products, where there may be limited study population size and potential feasibility and safety issues as
Drugs
AstraZeneca says it welcomes an FDA proposal for a novel excipient review program as it could “significantly de-risk the introduction of novel excipients into formulations for new marketed products and hence improve patient access to potentially life-enhancing medicines, as well as to encourage the use of a wider
Drugs
FDA has granted a priority review to an Eli Lilly NDA for selpercatinib and its use for treating patients with advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. The agency has set a user fee review action target
Devices
FDA has designated two Association for the Advancement of Medical Instrumentation standards as recognized consensus standards. By attaining FDA recognition, voluntary consensus standards can be used in premarket submissions to demonstrate conformity with relevant FDA regulations and requirements. The two are the newly updated ANSI/AAMI/ISO 14971:2019, a
Devices
FDA has cleared a BioIntelliSense 510(k) for the BioSticker on-body sensor for remote monitoring and care. It is a single-use device that provides continuous vital signs monitoring and actionable insights, the company says. Data are delivered to clinicians from patients in the home setting for early detection
Drugs
Johnson & Johnson says it is mobilizing resources at its Janssen unit to launch a multi-pronged response to the coronavirus outbreak. It says it has initiated efforts to develop a vaccine candidate against coronavirus and to broadly collaborate with others to screen a library of antiviral therapies. “Identifying compounds
Drugs
FDA has issued a guidance, Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, the document says, current labeling for antihypertensive drugs includes only the information that the drugs are
Drugs
The U.S. Pharmacopeia says it agrees with FDA’s position in a draft guidance on clinical immunogenicity considerations for biosimilar and interchangeable insulin products that a comparative clinical immunogenicity study generally will not be necessary to support a demonstration of biosimilarity or interchangeability. The comment letter says the agency
Drugs
CDER says it plans to publish 80 new and revised draft guidances in 14 categories during the 2020 calendar year. A notice lists the categories, with the number of guidances, as Biostatistics (3), Clinical/Antimicrobial (1), Clinical/Medical (10), Clinical Pharmacology (11), Drug Safety (8), Electronic Submissions (3), Generics (20)
Drugs
FDA says CDER has revised the Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements, to efficiently allocate limited resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants. An agency
Drugs
FDA has denied a Public Citizen 6/11/15 petition asking the agency to revise the Indications and Usage, Carcinogenesis, Mutagenesis, and Pregnancy sections of the labeling for Vanda’s Hetlioz (tasimelteon) capsules. The petition also asked that once the labeling is changed, FDA require distribution of a Medication Guide,
Devices
The California Superior Court has ordered Johnson & Johnson to pay $343.99 million in penalties for false and deceptive marketing of its pelvic mesh products for women. The California Department of Justice sued the company 5/2016 after a years-long multistate investigation showed the company had neglected to
Biologics
A 9/16-9/25/19 FDA inspection at R&B Medical Group, Van Nuys, CA, found significant deviations from regulations for human cells, tissues, and cellular and tissue-based products (HCT/P) in the company’s work as a testing laboratory that performs communicable disease testing under contract
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members, excluding consumer representatives, to serve on CDRHֺ’s Patient Engagement Advisory Committee. Nominations are being accepted for current and upcoming vacancies. To view the notice, click here.