Drugs
FDA is encouraging the pharmaceutical industry to comment on its project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured electronic submission approach. “Standardizing the format of structured data submission standardized format should increase the efficiency of FDA’
Drugs
FDA has approved commercial production at the new Kite CAR T-cell therapy manufacturing facility in Frederick, MD. Kite is a Gilead subsidiary. The site will produce Kite’s FDA-approved CAR T-cell therapy used to treat blood cancer, a company statement says. The statement says CAR T-cell
Drugs
FDA has published a draft guidance, Policy Regarding N-acetyl-L-cysteine, explaining the agency’s intent to exercise enforcement discretion for the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. An agency statement says the enforcement discretion policy would apply to products that
Drugs
FDA has published a guidance, Drug Products, Including Biological Products, that Contain Nanomaterials, providing guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The document says FDA does not categorically judge all products containing
Drugs
FDA has accepted for review a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating patients with anemia related to chronic kidney disease. The agency has set a 2/1/2023 user fee review action target date. The submission is based on data from the
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/21 voted unanimously 16-0 (one abstention) to recommend that the agency require future approvals of phosphatidylinositol 3-kinase (PI3K) inhibitors be supported by randomized clinical trial data. Panel members agreed with FDA reviewers’ concerns about toxicity and using overall response rates in
Drugs
FDA will accept comments for 60 days to a new public docket established on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. In a
Drugs
AbbVie has terminated its partnership with BioArctic AB to develop its portfolio of alpha-synuclein antibodies, including ABBV-0805 — a humanized monoclonal antibody targeting alpha-synuclein being investigated for treating Parkinson’s Disease. Their collaboration began in 2016 and in 2019 a Phase 1 study of ABBV-0805 was started.
Drugs
A CDER podcast gives drug companies the key elements in being “recall-ready.” The podcast refers to a final guidance that outlines preparations that firms should consider making to establish recall initiation procedures to ensure faster and more accurate recall actions. “FDA encourages companies to communicate quickly with supply chain
FDA Policy/General
FDA, in conjunction with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, has released the National Antimicrobial Resistance Monitoring System (NARMS) Integrated Summary 2019. An FDA statement says the summary combines antimicrobial resistance data in bacteria isolated from
Drugs
The Justice Department and FDA Office of Criminal Investigations say Gregory Settino, production supervisor of manufacturing at American Regent, formerly Luitpold Pharmaceuticals, has been sentenced to one year and one day in prison for theft of some $750,000 worth of medical products. Settino also was ordered to pay restitution
Drugs
Just published data from a study on the influence of data disclosures on physician decisions about off-label uses suggest that there is limited awareness of, and exposure to, unsupportive data about off-label uses among physicians. Writing in the journal BMC Primary Care, CDER Office of Prescription Drug Promotion
Drugs
FDA has issued Teva Pharmaceuticals and MedinCell a complete response letter on their NDA for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for treating schizophrenia. Without disclosing the reason for the rejection letter, the companies say they remain committed to developing the product and “will
Drugs
FDA has sent Warning Letters to 12 companies for selling unapproved over-the-counter (OTC) products intended to bleach or lighten the skin. The letters explain that these OTC skin lightening products containing the active drug ingredient hydroquinone are also not generally recognized as safe and effective. The group enforcement
Drugs
Harvard Medical School researchers say that study findings suggest that extrapolation by FDA beyond pivotal trial data to final indications is common, highlighting a need for closer postapproval monitoring. “Although extrapolations may be grounded in reasonable clinical predictions,” the researchers write in the Journal of the American Medical Association, they
Drugs
CDER attorney Christine Hunt says the Center does not object to additional information Covis Pharma wants to present at an upcoming public hearing on FDA’s proposal to withdraw approval for the company’s Makena (hydroxyprogesterone caproate injection). In a 4/18 letter to hearing presiding officer Celia Witten, Hunt
Drugs
A just-posted advisory committee briefing document reiterates FDA concerns with phosphatidylinositol 3-kinase (PI3K) inhibitors and their approval for treating hematological malignancies, setting the stage for a 4/21 discussion by the agency’s Oncologic Drugs Advisory Committee. Most of FDA’s concerns were outlined in a recent online
Drugs
A 10/18-11/5/21 FDA inspection at the Center for Rare Neurological Diseases clinical site operated by Dr. Daniel Tarquinio in Norcross, GA, found objectionable conditions in two clinical investigations. The inspection was conducted as part of the agency’s Bioresearch Monitoring Program, which helps ensure that the
Drugs
A 10/4-10/13/21 FDA inspection at the Vi-Jon drug manufacturing facility in St. Louis, MO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/31 Warning Letter says specific violations were: * failing to establish laboratory controls that include scientifically sound
Drugs
FDA oncology officials have outlined challenges with current PI3K inhibitors that have the agency reconsidering how the drugs can demonstrate safety and efficacy for their use in treating hematological malignancies. Writing in the 4/14 online Lancet Oncology, FDA Oncology Center of Excellence director Richard Pazdur and other FDA officials
Drugs
Drug sponsors should consider making race and ethnicity diversity plans an important part of their drug development plans, according to a law firm’s analysis of the agency’s recently published draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.
Drugs
Nektar Therapeutics and Bristol Myers Squibb have decided to end the clinical development program for bempegaldesleukin in combination with Opdivo (nivolumab) for treating renal cell carcinoma (RCC) and bladder cancer based on results from pre-planned analyses of two late-stage clinical studies of the combination therapy. In the Phase