Around the Web — 11.30.22
The FDA and the National Institute of Standards and Technology are collaborating on a project to develop and harmonize methods to standardize the description of the temperature
Michael Posey
November 30, 2022
The FDA and the National Institute of Standards and Technology are collaborating on a project to develop and harmonize methods to standardize the description of the temperature
FDA yesterday released a finalized guidance on “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile
FDA yesterday approved etranacogene dezaparvovec (Hemgenix, CSL Behring), an adeno-associated virus vector-based gene therapy for the treatment of adults with hemophilia B (congenital factor IX
A study shows that participants in many pivotal drug trials are recruited from low- and middle-income countries (LMICs), but country-level demographics are not usually reported
FDA issued warning letters to 5 firms for the unauthorized marketing of 15 different e-cigarette products that are packaged to look like toys, food, or
The FDA yesterday issued Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, a document that may help facilitate the development and approval
FDA yesterday granted accelerated approval for mirvetuximab soravtansine-gynx (Elahere, Immunogen) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian
Over the weekend, FDA Commissioner Robert M. Califf tested positive for COVID-19 while traveling on official agency business. FDA said he is up-to-date on vaccines
The FDA yesterday issued an emergency use authorization (EUA) for the first over-the-counter molecular test authorized for use with saliva specimens to Aptitude Medical Inc. for their
FDA announced yesterday it has awarded 19 new grants and 2 new contracts totaling more than $38 million in funding over the next 4 years