Drugs
An 11/12-11/19/22 FDA inspection at the Larkin Community Hospital institutional review board (IRB) in South Miami, FL, conducted as part of the FDA Bioresearch Monitoring Program, determined that the IRB did not adhere to applicable statutory requirements or FDA regulations governing the protection of human subjects
Drugs
FDA has accepted for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) extended-release tablets, novel serotonin (5HT) single receptor (1A) agonist that has demonstrated effectiveness and a favorable safety profile in clinical trials as monotherapy for major depressive disorder. This is the fourth attempt to get
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Acacia Pharma’s Byfavo (remimazolam), indicated for inducing and maintaining procedural sedation in adults undergoing procedures lasting 30 minutes or less. The regulatory review period is 4,482 days, of which 3,931 days
Devices
A 1/20 citizen petition submitted by the Service Employees International Union — United Healthcare Workers West calls on FDA to issue a “corrective recall” requiring modifications to specific hemodialysis machines manufactured by Fresenius USA. The petition asks that FDA require: * a modification to include an ultrafiltration settings screen that calculates
FDA Policy/General
Five King & Spalding attorneys say that in 2022 FDA issued nine enforcement letters targeting advertising and promotion violations for prescription drugs and medical devices. Their online post summarizes noteworthy trends and issues seen in the letters. Of the nine letters issued in 2022, four were from CDER’s Office
Devices
FDA has cleared a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patients aged six years and older. Tidepool Loop is described by the company as a patient-led project that allows insulin delivery from a compatible Apple Watch.
Drugs
Despite an appeals court decision suggesting FDA was wrong to base previous orphan drug exclusivity decisions on the uses or indications for which a drug is approved instead of all uses or indications within an orphan-designated disease or condition, a just-posted agency notice says it has considered the
Biologics
FDA is proposing to move to a flu vaccine-type model to have its vaccines advisory committee annually select Covid-19 strains in June for immunizations beginning no later than September each year. The agency says that if a serious “pathogenic vaccine-escape variant” begins circulating then an ad-hoc
FDA Policy/General
FDA has issued its long-awaited final guidance entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” Changes the agency made since a draft was released 7/2020 include “clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for
Drugs
Johnson & Johnson’s DePuy Synthes medical device unit has agreed to pay $9.75 million to resolve allegations it violated the False Claims Act by paying kickbacks to an orthopedic surgeon in Massachusetts to induce his use of DePuy products. The qui tam or whistleblower suit was originally filed
Devices
A citizen petition submitted 1/22 by Soft Lights Foundation asks FDA to issue regulations under 21 CFR Part 1040.41 to “regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use light-emitting diodes that pulse, flash, or strobe, and that these regulations set
Drugs
A 1/20 citizen petition submitted by the law firm Hyman, Phelps & McNamara on behalf of Curium U.S. LLC asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that relies on neutron capture technology given
FDA Policy/General
The National Advertising Division (NAD) of BBB National Programs says Novartis should discontinue making certain claims in a direct-to-consumer (DTC) ad for breast cancer drug Kisqali. The review was precipitated by a complaint about survival benefit claims lodged by Eli Lilly, the maker of competing drug Verzenio. Lilly
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of Emergency Use Authorizations (EUAs) for medical devices related to the Covid–19 public health emergency. The EUAs were issued from 6/16/2022 through 12/6/20222. To view the notice, click here.
Drugs
FDA has accepted for review a Blueprint Medicines supplemental NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis (SM). The agency set a user fee review action date of 5/22. Ayvakit is a kinase inhibitor currently approved for treating adults with advanced SM, including aggressive SM, SM
Drugs
In a move to help curb product shortages, FDA has issued an immediately-in-effect guidance on compounding certain ibuprofen products. The document describes regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for use in hospitals and health systems. An FDA notice
FDA Policy/General
Federal Register notice: FDA has classified computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions into Class 2 (special controls). The prescription devices are intended to provide a computerized version of condition-specific therapy as an adjunct to standard-of-care treatments for patients with gastrointestinal conditions. To view
FDA Policy/General
Federal Register notice: FDA has classified intense pulsed light devices for managing dry eye into Class 2 (special controls). The prescription devices are intended for use in the application of intense pulsed light therapy to the skin for patients with dry eye disease due to meibomian gland dysfunction, also known
Drugs
Covis Pharma’s Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in certain women should be withdrawn from the market because the drug does not have a favorable benefit-risk profile, says an FDA recommendation memo to FDA commissioner Robert Califf and chief scientist Namandjé Bumpus. The
Drugs
FDA has accepted for review an Intercept Pharmaceuticals NDA resubmission for obeticholic acid (OCA) for use in treating patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). In 2020, FDA issued a complete response letter on the company’s NDA that was seeking accelerated approval. The letter indicated
Devices
Medtronic has updated a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12 batteries for ongoing engineering analysis due to a potential weld nonconformance. The company says recent actions have been taken to improve control of the welding process after two
Drugs
FDA has announced a 4/19 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a postmarketing requirement (PMR) issued to NDA application holders for extended-release and long-acting opioid analgesics. The PMR is intended to evaluate the products’ long-term efficacy and the risk of opioid-induced