Biologics
FDA has approved the first Covid-19 vaccine — Pfizer-BioNTech’s vaccine that is now under the trade name Comirnaty — for use in individuals 16 years of age and older. The vaccine continues to be available under an emergency use authorization (EUA) for individuals 12 through 15 years of age
Drugs
FDA has posted its Prescription Drug User Fee Act VII commitment letter that describes enhancements to the program that will take place beginning 10/1/2022. The commitment letter’s goals and commitments will be discussed next month at a public meeting (see earlier story). Under the revised user fee
FDA Policy/General
Ortho-Cept Not Withdrawn Due to Safety/Efficacy: FDA8/20/2021 Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination
FDA Policy/General
DEVICES FDA has approved a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent ischemic strokes. The device was previously approved for closure of atrial septal defects up to 17 mm. The expanded was supported by data from the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0858). The revision pertains to guidance documents issued in 2017 and 2018 to
Drugs
FDA has release a revised draft guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. The document provides recommendations on how to meet the bioequivalence (BE) requirements set forth in the Federal Food, Drug, and Cosmetic (FD&C) Act and FDA regulations. It is applicable
FDA Policy/General
The Biden Administration reportedly has ruled out nominating FDA acting commissioner Janet Woodcock for the agency’s top post due to lawmakers’ objections. Based on government regulations, she can remain in her current acting role until mid-November. However, if a different nominee is named, then she can remain in
Drugs
CDER drug promotion researchers are evaluating how images can offer misleading perceptions in direct-to-consumer drug ads, in addition to developing validated instruments to measure other perceptions about such ads. In a CDER Office of Prescription Drug Promotion online post, the office discusses a recent study on images in
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDAs that
Devices
FDA has issued a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer has not been established. In addition, FDA says it is aware of reports
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk UC, an agency release says. Approval
Drugs
FDA says Pfizer has recalled four additional lots (to a total of 16) of its Chantix (varenicline) due to the presence of N-nitroso-varenicline above the company’s acceptable limit for the impurity. An online notice says the agency reminds consumers taking recalled Chantix to continue taking their current
Drugs
FDA has granted fast track designation for Senhwa Biosciences’ silmitasertib for treating patients with recurrent sonic hedgehog (SHH) driven medulloblastoma. The company says the designation makes it eligible to apply for accelerated approval and priority review when it meets relevant FDA criteria. Senhwa’s clinical partner, the Pediatric Brain Tumor
Devices
FDA has granted 510(k) clearance to medical image artificial intelligence provider Qure.ai for its brain CT quantification product qER-Quant. The company says clinicians can use the tool to rapidly and precisely assess the severity of injury in patients with conditions like traumatic brain injury, hemorrhagic stroke, and
Drugs
The Sedgwick recall index for the second quarter of 2021 shows drug and medical device recalls continuing to go down. The report says that medical device recalls fell for the fourth consecutive quarter, down 18.4% from the first quarter (212 recalls to 173), for a nine-quarter low. Software
Devices
FDA has cleared a Zimmer Biomet 510(k) for its Rosa Hip System for robotically-assisted direct anterior total hip replacement. The Rosa Hip is the fourth robotic system introduced by Zimmer Biomet and adds to the company’s product lines: Rosa Knee System for total knee arthroplasty, Rosa Partial
Devices
FDA has cleared a CardioNXT 510(k) for its heart treatment delivery platform, comprising the company’s iMap 3D Navigation & Mapping System, Activate Software, Sensor Enabled Axis Patient Patches, and MultiLink Sensor Enabled Catheter. The platform enables the examination of problematic cardiac tissue that is causing arrhythmias and directs
Drugs
The Natural Products Association is petitioning FDA to acknowledge NAC (N-acetyl-L-cysteine) as a legal dietary ingredient. A Nutraingredients.com online post says the molecule, a derivative of the L-cysteine amino acid and a precursor of the cellular antioxidant glutathione, has been on the market for decades
Devices
AdvaMed has commented on a CDRH discussion paper on “Conveying Materials Information About Medical Devices to Patients Healthcare Providers: Considerations for a Framework.” The trade association’s comments deal with the general framework, healthcare providers and patient labeling considerations, and materials listings.
Drugs
CDER has granted Covis Pharma Group’s request for a hearing on the Center’s 10/5/20 proposal to withdraw approval for Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly). An 8/18 CDER response to the Covis request grants the hearing and addresses other procedural issues related
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says online sponsored links for Eton Pharmaceuticals’ Alkindi Sprinkle (hydrocortisone) oral granules are false and misleading because they present information about the drug’s benefits and fail to include any risk information. An 8/4 Notice of Violation says the violations are
Drugs
FDA has granted GlaxoSmithKline an accelerated approval for Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or followed prior treatment and who have no satisfactory alternative treatment options. Jemperli’s efficacy