FDA Policy/General
FDA commissioner Robert Califf says the gap between FDA clearance or approval of a medical product and use of the product to treat patients “should be filled by an invigorated clinical research system that generates evidence that patients, clinicians, and health systems need to make well-informed decisions.” Writing in
Biologics
A day after Pfizer/BioNTech announced their submission of an emergency use authorization (EUA) request for a modified Covid-19 booster vaccine, Moderna 8/23 says it has submitted an EUA for a similar BA.4/BA.5 Omicron-targeting bivalent booster vaccine, mRNA-1273.222. Moderna's submission
Devices
Essilor International (Dallas, TX) has agreed to pay $16.4 million to resolve allegations that it violated the False Claims Act by paying eye care providers to order and purchase its optical lenses and equipment used to produce optical lenses. “The anti‑kickback statute prohibits offering or paying anything of
Biologics
Pfizer and BioNTech have filed a submission seeking FDA Emergency Use Authorization for their booster dose of an Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for individuals 12 years of age and older. “The application follows guidance from the FDA to include clinical data from the companies’
FDA Policy/General
Federal Register notice: FDA has announced a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss and vote on an Ipsen Biopharmaceuticals NDA for palovarotene capsules, indicated for preventing heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has posted a list of recent information collections that have been approved by OMB. They are: * Food Labeling: Notification Procedures for Statements on Dietary Supplements * Guidance for Reagents for Detection of Specific Novel Influenza A Viruses * Mitigation Strategies to Protect Food Against Intentional Adulteration * Tropical Disease
Drugs
FDA says that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee will review and discuss CDER’s proposed Quality Management Maturity (QMM) program 11/2. Under the program, the Center has proposed implementing a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at
Devices
FDA has issued a safety alert on autoinjector devices that are optional for use with multiple sclerosis therapy glatiramer acetate injection drug products due to incompatibility issues. According to the agency, there are currently three FDA-approved glatiramer acetate injection drug products on the market — all available in a single-
Drugs
FDA has issued Pharvaris a clinical hold on two clinical trials of its PHA121, an oral bradykini B2-receptor antagonist for treating and preventing hereditary angioedema (HAE) attacks. The hold followed the agency’s review of nonclinical data, according to the company, adding that a formal clinical hold letter is
Drugs
FDA has issued a revised draft guidance entitled “Charging for Investigational Drugs Under an IND: Questions and Answers.” The document answers frequently asked questions on FDA’s processes, policies and regulations about drug companies charging patients for investigational new drugs under certain circumstances in clinical trials or when expanded access
Devices
FDA has cleared a Koag 510(k) for its Vascette HP device, a topical vascular closure pad that uses a proprietary, plant-derived hemostatic foam. The device provides rapid hemostasis after cardiac catheterization without direct compression over the arterial puncture site (arteriotomy), according to the company. It is designed for
FDA Policy/General
National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci says he will be stepping down at the end of the year. Fauci, who also serves as chief medical advisor to president Joe Biden, says he is not retiring, rather pursuing the “next chapter of my career.” “Over the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820” (OMB Control Number 0910-0073). The collection covers FDA requirements that medical devices conform to GMPs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The collection covers various processes by which appeals requests regarding review of decisions or actions by CDRH may be submitted to the agency. To
Drugs
A new research article by FDA and European regulators finds their good clinical practice (GCP) inspection processes to be equivalent, which supports an ongoing inspection collaboration and inspection document sharing pact. Writing in the 8/16 online Therapeutic Innovation & Regulatory Science journal, the regulators said they analyzed 55 shared
Devices
FDA has classified as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronization therapy defibrillators due to reports about devices with a short circuit protection alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. “A
FDA Policy/General
FDA says the Covid-19 health emergency has provided insight into changing inspection activities to the extent it is initiating a new inspection planning system that will be more efficient, transparent, and adaptable to evolving needs. “This will help prioritize high-impact inspections such as those for facilities manufacturing Covid-
Drugs
A just-completed FDA inspection of Sun Pharmaceutical Industries’ Punjab, India manufacturing facility resulted in a six-item Form FDA-483. The form cited Sub for failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, the agency said a company investigation into
Drugs
India-based Cipla Ltd. has been issued a two-item Form FDA-483 after a 6/27-7/1 FDA inspection at its Madhya Pradesh, India manufacturing plant. According to the inspection form, the firm was cited for: * Equipment and utensils not being cleaned and maintained at appropriate intervals to
Drugs
FDA has revised an emergency use authorization for Pfizer’s Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-moderate Covid-19 to require a post-authorization clinical trial in patients with “Covid-19 rebound” and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-
Devices
FDA has cleared a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determining visual acuity. The on-demand, self-administered visual acuity test uses a combination of a touchscreen mobile device and computer connected to the internet, and it can
Devices
Attorney Keeley McCarty (SheppardMullin) says medical device manufacturers should be aware that the federal government is using False Claims Act prosecution to target manufacturers for off-label use of their devices, even where healthcare providers have decided the use is safe and effective. Writing in an online post, McCarty cites