Drugs
A 10/22-10/30/19 FDA inspection at Farmakeio Outsourcing, Southlake, TX, determined that the drug products produced at the outsourcing facility failed to meet the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify for
Drugs
FDA has accepted a Genentech sBLA and granted priority review for Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for specified people with non-small cell lung cancer. The company says FDA is reviewing the application under the real-time oncology review pilot program and is expected
Devices
Philips Respironics has recalled its V60 and V60 Plus ventilators that provide High Flow Therapy (software version 3.00 and software version 3.10), due to a risk to the patients if the system pressure reaches the default maximum limit. “This can occur if the oxygen flow is partially blocked
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Recall Authority--21 CFR Part 810” (Control Number 0910-0432). Section 518(e) of the Federal Food, Drug, and Cosmetic Act provides FDA with the authority in certain instances to issue an order requiring companies
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 6/4 notice about a draft guidance entitled Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. (XXX ITALICIZE ENTIRE TITLE XXX) Comments are now being accepted until 9/2. To view the
Drugs
A 10/7-10/28/20 FDA inspection at Syntec Pharma, Farmingdale, NY, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A just-released 7/6 Warning Letter identifies the deviations as: * failing to perform repackaging, relabeling, or holding of API under appropriate CGMP
Devices
FDA has cleared an Abbott 510(k) for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon Software. The software combines OCT with artificial intelligence (AI) to provide physicians a better view of coronary blood flow and blockages to assist physician decision-making and
Drugs
FDA has lifted a partial clinical hold on Novartis’ investigational gene therapy OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA). The decision to lift the hold was based on data from Novartis’ comprehensive nonclinical toxicology study in non-human primates that addressed all issues identified, including questions
FDA Policy/General
A Senate appropriations subcommittee has voted to advance FDA’s fiscal year 2022 budget that would give the agency a $200 million (6%) spending boost. The subcommittee approved FDA’s total funding at $3.414 billion, which (XXX SPELLING XXprovides increases for food (XXX DELETE XXand medical product safety activities.
Devices
FDA has cleared a RealView Imaging 510(k) for its Holoscope-i holographic system for creating spatially accurate, three-dimensional interactive medical holograms based on data received from standard CT scans and 3D ultrasound systems. The device features an over-the-head system configuration suspended above the physician, without the
FDA Policy/General
Federal Register notice: FDA is denying a request for a hearing submitted by Vithal K. Patel and issuing an order debarring him for one year from providing services in any capacity related to an approved or pending drug product application. FDA bases this order on a finding that Patel was
FDA Policy/General
Federal Register notice: FDA is denying Belen G. Ngo’s request for a hearing and is issuing an order debarring her for five years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that
Drugs
FDA has approved an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Approval was based on data from the two TULIP Phase 3 trials and the MUSE Phase 2I trial. Data showed that “more patients treated
FDA Policy/General
Federal Register final rule: FDA has issued a final rule to amend its medical product “intended use” regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act. The rule also withdraws
Drugs
FDA finds itself defending the accelerated approval process in the wake of Biogen’s controversial approval for its Alzheimer’s therapy Aduhelm (aducanumab), and a new BMJ report that since the program’s inception in 1992, nearly half (112) of the 253 drugs authorized have not been confirmed as clinically
Devices
FDA has granted Biofourmis a breakthrough device designation for BiovitalsHF, a software medical application that is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. It specifically is designed to assist with guideline-directed medical therapy in patients with heart failure
FDA Policy/General
Device User Fee Rates for FY 2022 7/30/2021 Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022. The standard fees are as follows: PMA or efficacy supplement ($374,858); panel-track supplement ($281,143); de novo classification request ($112,457); 180-
FDA Policy/General
Ariad Pharmaceuticals has agreed to be acquired by Takeda Pharmaceutical Co. in a deal valued at about $5.2 billion. Takeda will pay $24 in cash for each Ariad share owned for a premium of about 75% over Ariad’s recent closing price. Astellas Pharma has completed an acquisition of
FDA Policy/General
Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022. The standard fees are as follows: PMA or efficacy supplement ($374,858); panel-track supplement ($281,143); de novo classification request ($112,457); 180-day supplement ($56,229); real-time supplement ($26,240); and
FDA Policy/General
Federal Register notice: FDA has announced a 10/7 Antimicrobial Drugs Advisory Committee meeting. It is scheduled to discuss a Takeda Pharmaceuticals NDA for maribavir oral tablets for treating adults with post-transplant cytomegalovirus infection, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. To view the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Request for Samples and Protocols” (OMB Control Number 0910-0206). The collection supports agency regulations giving it the responsibility to prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that
Drugs
FDA has revised Regeneron’s emergency use authorization (EUA) for Regen-Cov (casirivimab and imdevimab expanding its emergency use as post-exposure prophylaxis (prevention) of Covid-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression