Biologics
Days after CBER director Peter Marks joined the Trump administration’s Operation Warp Speed project to develop a coronavirus vaccine, he left the group to resume his full-time work at FDA. In a lengthy article based on anonymous interviews with current and former HHS and other officials, Politico says
Drugs
FDA has issued a compliance guide for inspections of CDER-led or CDRH-led combination products. The document says that a single establishment inspection report and, where applicable, FDA-483 should be used to document all observations made during an inspection at a combination product manufacturer. The guide’s contents
Drugs
FDA has accepted for review a PharmaEssentia BLA for ropeginterferon alfa-2b (P1101), a novel pegylated interferon intended for treating rare blood cancer polycythemia vera in the absence of symptomatic splenomegaly. Polycythemia vera begins in a disease-initiating stem cell in the bone marrow that results in a chronic red
Drugs
FDA has approved a Merck NDA for Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. The drug was previously approved to treat patients with complicated urinary tract infections and
Drugs
FDA has issued an immediately-in-effect guidance, Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the Covid-19 Public Health Emergency, to apply to IRB review of only individual patient expanded access INDs. The document does not apply to
Drugs
FDA has extended by three months its review of a Novartis supplemental BLA for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. The revised user fee review action date is now expected in September. Ofatumumab is a fully human anti-CD20 monoclonal
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on, among other things, bioequivalence study designs to support ANDA submissions. To view the notice, click here.
Drugs
FDA says it is making its Covid My Studies app (formerly known as FDA My Studies) available to investigators as a free platform to obtain informed consent from patients for eligible clinical trials when face-to-face contact is not possible or practical due to Covid-19 control measures. An
Drugs
FDA has issued an immediately-in-effect guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency, to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial
Devices
FDA has cleared a Welldoc 510(k) to add a new feature to its digital health product BlueStar Rx which supports individuals using long-acting insulin. The Insulin Adjustment Program (IAP) supports the process of basal insulin titration by health care providers for adults with Type 2 diabetes, according to
Drugs
The Motley Fool, a financial and investing advice company, says the FDA Drug Competition Action Plan initiative that the agency started in 2017 to make prescription drugs more affordable has worked well for consumers, but at the expense of lower revenue and profits for many companies. In an online post,
Devices
FDA has granted Noctrix Health a Breakthrough Device Designation for its wearable NTX100 neuromodulation therapy designed for treating adults with primary moderate-severe restless legs syndrome (RLS) who are refractory to medications. RLS is the second most common sleep disorder in the world and impacts over 10% of the adult
Drugs
University of Washington professor of medicine and epidemiology Bruce Psaty says an FDA draft 2020 guidance on evaluating the safety of new drugs for improving glycemic control “represents a serious step backward.” Writing in a comment letter, Psaty says an earlier 2008 guidance “revolutionized the quantity and quality of information
Drugs
The Association of American Physicians and Surgeons has filed suit against FDA in western Michigan federal court to force the agency to stop limiting access to hydroxychloroquine, a drug touted by president Trump, for prophylactic use against Covid-19. The conservative nonprofit group’s complaint alleges that the agency is
Drugs
Quantitative methods and modeling (QMM) covers a broad spectrum of tools that can be used in modernizing generic drug development, says FDA in an online Regulatory Science Impact Story. The post says that in both new and generic drug development, mathematical models can be thought of as knowledge management systems
Drugs
CytoDyn has filed a BLA for Pro 140 (leronlimab (PRO 140) for use in combination therapy for treating HIV infection. Leronlimab is described as an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases. The company says
Drugs
FDA says that since the beginning of the Covid-19 pandemic it has been working to facilitate the development and availability of drugs for use by patients, doctors, and health systems as expeditiously as possible. In an online paper, CDER says several therapies are being tested in clinical trials to
Drugs
An FDA-issued safety alert warns health care professionals about the temporary absence of a “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents. Vecuronium bromide for injection 10 mg per vial and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL,
Drugs
An 11/25-12/11/19 FDA inspection at LifeHealth Science, Twinsburg, OH, found multiple serious violations in the firm’s manufacturing and distribution of its ORËÁ dietary supplement. A 5/15 Warning Letter says that claims on the firm’s Web site establish that the product is considered to
FDA Policy/General
Federal Register notice: FDA has announced its process for publishing FDA Emergency Use Authorizations (EUAs) for medical devices related to the Covid-19 public health emergency. FDA is not publishing a separate Notice of Availability (NOA) for each Covid–19 related EUA, but instead it intends to publish periodically a
Drugs
FDA commissioner Stephen Hahn says the agency has updated guidances to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in the hand sanitizer products. “FDA appreciates industry’s willingness
Drugs
Amneal Pharmaceuticals is recalling all lots of metformin HCl extended-release tablets, 500 mg and 750 mg after being informed by FDA that its testing of seven lots showed N-nitrosodimethylamine amounts above acceptable FDA levels. The agency recommended a recall of the seven tested lots, according to an online