FDA Policy/General
Novartis says FDA research into quantitative claims in direct-to-consumer (DTC) prescription drug ads could be improved if the examples drawn from DTC ads in the marketplace could include for testing some examples of ads that are consistent with FDA product labeling. The company’s comment letter also says
Devices
FDA has issued a letter to healthcare providers to ensure they are aware of the current indications and instructions for use for the NuVasive Precice Intramedullary Limb Lengthening (IMLL) system, including Precice Short. An online update reminds providers that the IMLL device should be removed after one year. “Precice devices
Devices
FDA has cleared a Candela 510(k) to expand the labeled indication of its Vbeam Pulsed Dye Laser for use of the 595 nm wavelength to include treating pediatric cutaneous capillary malformations, also known as port wine stains, and infantile hemangiomas/congenital hemangiomas. The company says port wine stains affect
Devices
FDA has cleared an Overjet 510(k) to expand the use of its artificial intelligence (AI) technology for predicting tooth decay in younger patients. The clearance covers the use of Overjet’s AI models for detecting and outlining caries (cavities) on periapical and bitewing radiographs for patients aged 12 years
Drugs
FDA has approved a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treating pediatric patients (three years of age and older) who have growth failure due to inadequate secretion of endogenous growth hormone. Approval is based on data from a
Drugs
FDA has issued Eton Pharmaceuticals a second complete response letter (CRL) on its NDA for dehydrated alcohol injection for treating methanol poisoning, citing chemistry manufacturing and controls issues. The company says all issues in the CRL are “addressable” and it will develop a comprehensive action plan to address the concerns.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document describes the agency’s interpretation of the statutory prohibition on wholesaling certain compounded drugs, and how it intends to apply the provision. To
Drugs
FDA has released the form FDA-483 issued following a 2/23-3/3 inspection at the Prisma Health outsourcing facility in Simpsonville, SC. The four inspection observations were: * failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are deficient in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The document provides recommendations for prescription drug and biological products. It also offers recommendations on how to make the language and presentation consumer friendly.
Drugs
FDA says all drugs and drug products manufactured by Chengdu KeCheng Fine Chemicals in Chengdu Shi Sichuan Sheng, China, were placed on an Import Alert 6/8. A 6/20 Warning Letter says the action follows several company refusals to provide records and other information sought by the agency. Chengdu
Drugs
Eli Lilly says new Phase 2 data on weight-loss candidate retatrutide met primary and secondary endpoints. After 24 weeks, it met the primary endpoint by demonstrating a mean weight reduction up to 17.5% (41.2 lb. or 18.7 kg), the company says. In meeting the secondary endpoint,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Imports and Electronic Import Entries.” The collection supports regulations that outline the required data elements that respondents must submit when importing, or offering for import, an FDA-regulated article into the U.S. The revision addresses revised
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of a Gemini Laboratories’ NDA for Oxandrin (oxandrolone) tablets and four ANDAs that reference the product due to safety concerns. The anabolic steroid is indicated for promoting weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in
Drugs
A 4/11-5/11/22 FDA inspection at the Safe Chain Solutions wholesale drug distribution facility in Cambridge, MD, found violations of the Drug Supply Chain Security Act (DSCSA). A 6/8 Warning Letter says FDA observed that the company did not have adequate verification systems in place, failed
FDA Policy/General
FDA has published a guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, with recommendations for presenting the cited information in promotional labeling and ads for prescription human drug and biological products, prescription animal drugs, and in DTC promotional labeling for over-the-counter
Drugs
The FDA Oncology Center of Excellence (OCE) is working with the Reagan-Udall Foundation to evaluate essential data elements that could provide a starting point for characterizing the data sources and study design of an early real-world data study proposal. Writing in an FDA Voices online post, OCE associate
Drugs
Senate majority leader Chuck Schumer (D-NY) says Congress should approve a four-prong legislative solution to the growing nationwide problem of drug shortages. He also called on FDA to activate a plan to limit shortages. Speaking at a hospital in upstate New York, Schumer said, “I am not only
Drugs
FDA has published a draft guidance, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act, describing the agency’s interpretation of, and policies concerning, the prohibition on wholesaling compounded drugs in Section 503B of the Federal Food, Drug, and Cosmetic Act. The document also describes
Biologics
FDA has issued a complete response letter (CRL) on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye drug for treating patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. The submission is being held up “solely due to an
Biologics
FDA has approved a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. The company describes the subcutaneous infusion as a IgG4 monoclonal antibody that binds to the neonatal Fc receptor,
Devices
Former DePuy Synthes sales representative Matthew Capobianco of Winchester, MA, was arrested 6/26 on eight counts of wire fraud and one count of making false statements in a case investigating his interference with a Boston-area hospital’s sterilization processes. A government indictment contends that from 1/2016 through
FDA Policy/General
In an update, FDA commissioner Robert Califf says additional changes will be made to the agency’s new Human Foods Program (HFP) and the Office of Regulatory Affairs (ORA) to enhance coordination, prevention, and response activities across FDA. In a media statement, Califf says the changes are based on recommendations