Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says pages at the Xeris Recorlev Web site make false or misleading claims and representations about the safety and efficacy of Recorlev (levoketoconazole) tablets, oral. A 6/7 Notice of Violation says the violations “are especially concerning from a public health perspective
Drugs
The FDA Accelerating Rare disease Cures (ARC) program used its first year to strengthen internal and external partnerships with stakeholders and engaged with outside experts to help find solutions for the challenges in rare disease drug development. That’s the report of CDER associate director for rare diseases Kerry Jo
Devices
An FDA update says GE HealthCare has conducted preliminary testing on its newly manufactured neonatal incubators that suggests the potential for higher levels of formaldehyde that rapidly decrease over one week. The update is part of the agency’s ongoing evaluation of published literature that found elevated levels of formaldehyde,
Devices
FDA has granted Futura Medical a de novo marketing authorization for over-the-counter MED3000, a topical gel formulation for treating erectile dysfunction (ED) . MED3000 works through a “unique evaporative mode of action,” according to the company. The non-medicated hydro-alcoholic gel's authorization is based on data
FDA Policy/General
Federal Register notice: FDA is issuing an order to debar Luis Anarbol Moran for five years from importing any drug into the U.S. The agency bases this on a finding that Moran was convicted of one felony count. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Orphan Drugs — 21 CFR Part 316.” The collection supports FDA regulations that outline requirements for obtaining approval of an orphan drug and the conditions for obtaining seven-year exclusivity for such products. To view the notice, click
FDA Policy/General
The Biotechnology Innovation Organization (BIO) says it applauds FDA efforts to embark on a data and technology modernization strategy consistent with PDUFA 7 commitments and FY 2023 Omnibus Bill requirements. “BIO encourages FDA to think strategically and would welcome opportunities to provide feedback as FDA’s strategy evolves,” the association
Drugs
Viatris is petitioning FDA to require additional pharmacokinetic (PK) and pharmacodynamic (PD) studies to support an NDA submitted by ARS Pharmaceuticals for neffy (epinephrine nasal spray) or ARS-1 intranasal epinephrine for the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in adults and some children. The petition says
Drugs
FDA has approved Ipsen’s Bylvay (odevixibat) for an expanded use — treating cholestatic pruritus in patients aged 12 months and older with Alagille syndrome (ALGS). The once-daily, non-systemic ileal bile acid transport inhibitor acts locally in the small intestine and has minimal systemic exposure, according to the company.
Biologics
FDA reviewers are recommending that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant, which is currently the predominant strain in the U.S. In a just-posted briefing document released in advance of a 6/15 Vaccines and Related
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)). The collection supports FDA regulation requiring manufacturers and user facilities to report medical device-related deaths, serious injuries, and malfunctions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Premarket Notification of Devices.” The agency is revising the collection to include Form FDA 3674, “Certification of Compliance, Under 42 U.S.C., 282(j)(5)(B), with Requirements of ClinicalTrials.gov.” It is also being revised
Drugs
FDA has published a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests. The document describes the policies used in the Office of Pharmaceutical Quality, the Office of Compliance, and the Office of Generic Drugs for assessing requests for
Drugs
FDA has approved an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) to treat functional constipation in pediatric patients aged six to 17 years. Linzess is the first treatment for this condition and the recommended dosage is 72 mcg orally once daily, according to an agency release. Commonly experienced by children
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health.” The collection supports the voluntary submission of such allegations to help FDA identify potential risks to patients and determine whether further investigation is
Devices
BearCare has recalled (Class 1) its rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation from using the devices. “Potential overheating and leakage of corrosive chemicals from the device could cause skin irritation, burns, other serious injuries, or death,” a recall notice says. To date, the
Drugs
FDA has accepted for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a first-in-class potassium-competitive acid blocker to treat erosive gastroesophageal reflux disease (erosive esophagitis). The company says the resubmission responds to an agency 2/2023 complete response letter relating to specifications and controls for a nitrosamine
Devices
FDA has cleared a GE HealthCare 510(k) for the Sonic DL – a deep learning-based technology designed to dramatically accelerate image acquisition in magnetic resonance imaging (MRI). “Sonic DL enables new imaging paradigms, such as high-quality cardiac MRI in a single heartbeat,” the company says. The device is
Biologics
FDA has approved a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin (nadofaragene firadenovec-vncg) and the company’s plan to scale-up its drug substance manufacturing process at FinVector Oy located in Kuopio, Finland. The company says supplies from the scale-up process manufactured at FinVector’s facility
FDA Policy/General
FDA needs new policies geared toward integrating artificial intelligence (AI) into drug and medical product development, according to former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis. Writing in the 6/8 online JAMA Forum, they say that integrating AI “technologies into the current regulatory frameworks
Devices
FDA is alerting health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of its Quadrox oxygenators and certain Getinge/Maquet venous hardshell cardiotomy reservoirs due to potentially compromised packaging sterility that may result in the risk of infection and
Drugs
FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee 6/9 voted 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogen’s Leqembi (lecanemab) in the early treatment of Alzheimer’s disease. Eisai received accelerated approval for Leqembi 1/