Drugs
FDA has released the FDA-483 issued following a 10/18-10/26/21 inspection at the Catalent Belgium fill and finish drug manufacturing facility in Brussels, Belgium. The seven inspection observations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components
Drugs
An FDA review of records supplied by Cosmo Bio Co., a Yuseong-gu Daejeon, South Korea, manufacturer of over-the-counter drug products, identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. A 1/6 Warning Letter says specific violations were: * failing to have, for each
Drugs
FDA has issued Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and distress associated with Prader-Willi syndrome (PWS). CDER’s Division of Psychiatry concluded that, while LV-101 appears to be generally safe and well tolerated, the
Drugs
FDA has extended by three months the user fee review action dates on two bluebird bio BLAs for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy. The new review action target dates for beti-cel and eli-cel
Devices
FDA and the medical device industry have reportedly come to a standstill in their negotiations on the next five-year iteration of the medical device user fee agreement. A 1/15 deadline to submit their negotiated final commitment letter to Congress has come and gone without the two parties budging
FDA Policy/General
DEVICES FDA has cleared a Bone Index Ltd. 510(k) for its second generation Bindex point-of-care device model to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a “Density Index,” a parameter which estimates bone mineral density at
FDA Policy/General
HUMAN DRUGS FDA has approved an Allergan NDA for Byvalson (nebivolol and valsartan) 5 mg/80 mg tablets, indicated for treating hypertension to lower blood pressure. The company says the product is the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the U.
FDA Policy/General
Pepcid Not Withdrawn Due to Safety/Efficacy: FDA 1/14/2022 Federal Register notice: FDA has determined that Valeant Pharmaceuticals’ Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. Pepcid is indicated in adult and pediatric patients for treating active
FDA Policy/General
Adventrx Pharmaceuticals has provided details on a Phase 3 clinical study it plans to initiate this quarter of ANX-188 (purified poloxamer 188) in sickle cell disease. The study will be conducted at about 40 sites mostly in the U.S. with a primary objective of demonstrating that ANX-188
Drugs
FDA has approved a Glenmark Specialty NDA for Ryaltris (olopatadine HCl and mometasone furoate) a fixed-dose (metered) nasal spray for treating seasonal allergic rhinitis symptoms in adults and pediatric patients 12 years of age and older. Each nasal spray unit contains 665 mcg of olopatadine HCL, a histamine-1
FDA Policy/General
Federal Register notice: FDA has determined that Valeant Pharmaceuticals’ Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. Pepcid is indicated in adult and pediatric patients for treating active duodenal ulcer, active gastric ulcer, symptomatic nonerosive gastroesophageal reflux disease, and
FDA Policy/General
Federal Register notice: FDA is classifying electrocardiograph software for over-the-counter use into medical device Class 2 (special controls). The action is based on an Apple Inc. request for de novo classification of its ECG App. The device is identified as one that creates, analyzes, and displays electrocardiograph data
Drugs
An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) has led to a five-page Form FDA 483 that cited several GMP deficiencies. For example, the agency said aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, the 483 says environmental surface sampling
Drugs
FDA has approved a Pfizer NDA for Cibinqo (abrocitinib), an oral Janus kinase 1 inhibitor for treating adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics.The drug is approved for recommended doses of 100 mg
Devices
FDA has cleared a Nextremity Solutions 510(k) for its InCore Subtalar System, indicated for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The device provides surgeons with a three-part intraosseous fixation option for subtalar joint arthrodesis, according to the
Drugs
A new Government Accountability Office (GAO) report finds that FDA needs better planning for its recruitment and retention of medical product staff. The GAO examination was required as part of the 2016 21st Century Cures Act that provided additional flexibilities regarding FDA’s recruitment and retention of medical product staff.
FDA Policy/General
Federal Register notice: FDA is announcing a 3/10 virtual public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed. To view the notice, click here.
Drugs
Cato Institute senior fellow Jeffrey Singer, a general surgeon, and American Council on Science and Health director of chemical and pharmaceutical science Josh Bloom say two FDA requirements that are part of the emergency use authorizations for two Covid-19 antiviral drugs “all but guarantee that most people who need
Drugs
FDA has informed Denali Therapeutics that it has placed a clinical hold on the firm’s DNL919 IND, an Alzheimer’s candidate. Denali says an agency e-mail indicated that an official clinical hold letter would be provided in about 30 days.
Devices
FDA has released the first nine safety summaries developed by the agency and ECRI from a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. The summaries are for materials that are commonly used in implantable medical devices and
Drugs
GlaxoSmithKline and Vir Biotechnology have asked FDA to approve an expanded emergency use authorization (EUA) for the Covid-19 monoclonal antibody treatment sotrovimab to include intramuscular administration. FDA approved the sotrovimab EUA 5/2021 as an investigational single-dose intravenous infusion for the early treatment of SARS-CoV-2. The
Drugs
A Miami, FL, woman who co-owned Unlimited Medical Research, a clinical research site, pleaded guilty 1/12 to obstructing a 2017 FDA regulatory inspection with an alleged scheme to fraudulently falsify clinical trial data. The Department of Justice says that as part of a plea agreement, Olga Torres admitted