Devices
FDA has published a guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, to describe relevant information that should be included in test report summaries, test protocols, and complete test PMA applications, HDE applications, 510(k) submissions, IDE applications, and De Novo requests. For
FDA Policy/General
FDA has published a guidance, Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization, indicating that for ENDS products without agency authorization, FDA intends to prioritize enforcement against: * any flavored, cartridge-based ENDS product (other than tobacco- or menthol-flavored ENDS
Devices
Neovasc has submitted a PMA for its Neovasc Reducer for treating refractory angina. The device is intended to relieve angina symptoms by altering blood flow within the heart’s myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle, the company says. Placement of the
Drugs
Some drug manufacturers, including Bristol-Myers Squibb, Gilead, Pfizer, GlaxoSmithKline, Sanofi and Biogen have started the new year with higher prices on more than 250 drugs. Reuters reports on data analyzed by 3 Axis Advisors, a healthcare research firm, showing that nearly all of the increases were less than 10%
Biologics
Mesoblast has submitted as part of a rolling BLA clinical efficacy and safety data for remestemcel-L, indicated for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). The final module will be filed later this month and Mesoblast says it will request an expedited review. The
Drugs
FDA has issued a draft guidance, Bridging for Drug-Device and Biologic-Device Combination Products, with recommendations for approaching bridging in NDAs or BLAs for drug-device or biologic-device single entity or co-packaged combination products. The document covers: * bridging of information related to a combination product that employs
Drugs
FDA has issued a draft guidance, Demonstrating Substantial Evidence of Equivalence for Human Drug and Biological Products, to guide applicants planning to file NDAs or BLAs or supplemental applications on the evidence to be provided to demonstrate effectiveness. The document complements and expands on a 1998 guidance. The guidance says
FDA Policy/General
Federal Register notice: FDA is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. The rule is intended to improve and make more efficient the agency’s premarket submission program
FDA Policy/General
Federal Register: FDA has made available a draft guidance entitled “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.” The document addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and BLAs are expected to be submitted on
Drugs
FDA has approved the expanded use of Amarin’s Vascepa’s (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk factors. Last month, the agency’s Endocrinologic and Metabolic Diseases Advisory Committee voted 16
Devices
FDA has authorized the de novo marketing of Tandem Diabetes Care’s Control-IQ Technology, an interoperable automated glycemic controller device that adjusts insulin delivery by connecting to an alternate controller-enabled (ACE) insulin pump and integrated continuous glucose monitor (iCGM). “This is the first such controller that can be
FDA Policy/General
Federal Register notice: FDA has issued a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterilized by irradiation. Repealing the irradiation regulation will mean that over-the-counter drug products that are generally recognized as safe and effective
Devices
FDA has cleared a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope, which is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. Traditionally, duodenoscopes have been intended for use on multiple patients,
Drugs
FDA has released a draft guidance on “Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.” The document’s development was mandated in the 21st Century Cures Act under section 507, Qualification of Drug Development Tools (DDTs). Once finalized, FDA says the document will represent the agency’
Devices
Futura Medical says it intends to pitch to FDA a medical device regulatory approval pathway for the placebo arm from the European erectile dysfunction (ED) Phase 3 study FM57 after the placebo arm outperformed the active study drug, MED2005 (nitroglycerine) gel. The placebo gel contained the company’s proprietary transdermal
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. The agency is also requesting nominations for a nonvoting industry representative to serve on the committee. A nominee may either be self-nominated
Devices
FDA says it has qualified the IMAnalytics with MRIxViP1.5T/3.OT and BCLib extraction and evaluation tool through the Medical Device Development Tools (MDDT) program. An agency statement says this is the first computational modeling tool that can be used across a wide range of active implantable medical devices
Drugs
FDA has released the FDA-483 with seven observations from a 6/10-7/18 inspection at Exela Pharma Sciences, a Lenoir, NC, outsourcing facility. The observations were: * failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are
Drugs
A December CDER Webinar for NDA applicants and holders, patent holders, and regulatory professionals explains updates made to forms FDA 3542a and 3542. The presentation by CDER’s Alicia Chen says the forms were updated to (1) reduce the time needed to complete and process the forms, (2) update certain
Drugs
FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and
FDA Policy/General
The Senate 12/12 confirmed Stephen Hahn as the next FDA commissioner on a floor vote of 72-18. President Trump nominated the MD Anderson chief medical officer 11/1, the same day former acting commissioner Ned Sharpless was ordered back to his previous position as National Cancer Institute director.
Devices
FDA has authorized the de novo marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Newborn screening uses a small amount of blood from an infant’s