Drugs
FDA has published an immediately effective new final guidance, Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid-19 Prevention or Treatment, to give sponsors and investigators considerations for approaches on how common Covid-19-related symptoms can
Drugs
The three top Democrats on the House Energy and Commerce Committee are urging FDA commissioner Robert Califf to quickly issue a congressionally mandated guidance on clinical trial diversity action plans that was due on 12/29/2023. In their 2/20 letter, Reps. Frank Pallone (D-NJ), Anna Eshoo (D-
Drugs
An FDA safety alert is warning healthcare professionals and consumers about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin. “These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce
Drugs
United Therapeutics says it is suing FDA over the agency’s decision to permit Liquidia Corp. to add a second proposed indication to its NDA for Yutrepia (treprostinil) inhalation powder. In a statement, United says FDA mistakenly permitted Liquidia to amend its NDA and “skirt longstanding FDA rules, precedents, and
Drugs
CBER has issued a standard operating policy and procedure (SOPP), Postmarketing Requirement/Commitment Related Submissions — Administrative Handling, Review, and CBER Reporting, that applies to all postmarketing requirements (PMRs) and commitments (PMCs) for licensed biologics and drugs approved under an NDA regulated by CBER. The SOPP says that CBER will: * accurately
Drugs
Two policy executives with the Coalition for a Prosperous America say there are steps FDA, Congress, and other federal agencies could take to reduce drug shortages and the threat of medical device shortages. In a deeply-researched article in American Affairs, Nick Iacovella and Jon Toomey lay much of the
Drugs
In a study funded by FDA, academic and FDA researchers who surveyed doctors about their experiences with Risk Evaluation and Mitigation Strategies (REMS) for eight REMS-covered drugs found that most doctors said the REMS certification process provided useful information about the drugs but wanted more information on their benefits
Drugs
FDA has granted Harmony Biosciences Holdings an orphan drug designation for pitolisant and its use in treating Prader-Willi syndrome (PWS). The company says about 20,000 people in the U.S. have PWS, and the majority experience behavioral symptoms and more than half suffer from excessive daytime sleepiness. The
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel), followed by Keytruda as a single agent for treating patients with primary advanced or recurrent endometrial carcinoma. The agency has set a user fee review action target
Drugs
ARS Pharmaceuticals says it will submit in the second quarter its nasal allergen challenge study data as part of a response to a 9/2023 FDA complete response letter on an NDA for neffy (epinephrine nasal spray) for treating Type 1 allergic reactions, including anaphylaxis, in adults and some children.
Drugs
A 9/4-9/8/2023 FDA inspection at Sichuan Deebio Pharmaceutical Co. Ltd., in Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/14 Warning Letter says specific deviations were: * failing to follow and document laboratory controls at the
Drugs
FDA has placed a clinical hold on a RAPT Therapeutics Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis and a Phase 2a trial in asthma. The action was based on a serious adverse event — liver failure — in one patient in the atopic dermatitis trial, according to the company. The
Drugs
An online Clinical Leader guest column raises the question of why the drug industry is resisting quality management changes that FDA so clearly supports. PDC Pharma Strategy CEO Penelope Przekop, a quality management expert, says that at a recent meeting of agency representatives and stakeholders to discuss the challenges and
Drugs
Gilead Sciences says it has paused enrollment globally in its magrolimab solid tumor studies and FDA subsequently requested a partial clinical hold on these as well. The hold is in addition to the previously announced full clinical hold on all magrolimab studies in acute myeloid leukemia and myelodysplastic syndromes requested
Drugs
FDA has published 29 new and 33 revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The agency will receive public comments before finalizing the guidances. Some 50 of the PSGs are for products with no approved ANDAs, including 27 complex
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The CDER Drug Safety Priorities report for FY 2023 “features the many ways in which CDER continued to be involved in promoting and protecting public health, as well as ongoing activities to address the national drug overdose crisis.” The report says the Center’s efforts included strategies to address the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA virtual meeting on advancing the development of therapeutics through rare disease patient community engagement “provided a critical forum to discuss best practices and opportunities for engaging with rare disease patients and other key stakeholders throughout the rare disease drug development
Drugs
FDA is increasing its educational outreach to decrease public hesitancy with biosimilar usage which may be caused by lack of experience with the products or a lack of understanding of what biosimilars are and how the agency reviews and approves them. CDER Office of Therapeutic Biologics and Biosimilars (OTBB) has
Drugs
FDA has granted Mesoblast an orphan drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart condition hypoplastic left heart syndrome. The designation is based on data from a randomized controlled trial, which the company says demonstrated that a single intramyocardial administration of Revascor at the
Drugs
FDA is several weeks late in issuing a guidance on how and when drug and medical device companies must submit diversity action plans for clinical trial research, according to a Regulatory Affairs Professionals Society (RAPS) Regulatory Focus online post. The December 2022 Food and Drug Omnibus Reform Act requires manufacturers
Drugs
FDA has granted Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in recently diagnosed Stage 3 Type 1 diabetes patients with the genotype HLA DR3-DQ2. Antigen-specific therapy Diamyd is currently being evaluated in what the company calls the first-
Drugs
Harvard Medical School assistant professor of medicine Peter Cohen says FDA is not doing all it could to keep harmful products sold as dietary supplements out of the hands of consumers. Interviewed 2/13 on the PBS News Hour, Cohen specifically referenced tianeptine, commonly known as “gas station heroin” and