FDA Policy/General
A Senate pandemic-related bill that outlines many new FDA responsibilities is headed to the Senate floor for a vote after being marked-up 3/15 by Health, Education, Labor and Pensions (HELP) Committee members. The Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT
Drugs
Pfizer and BioNTech have submitted an FDA Emergency Use Authorization application for a second booster dose in adults 65 years of age and older who have received an initial booster of any of the authorized or approved Covid-19 vaccines. The submission is based on two real-world data sets
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorizations issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT–PCR Diagnostic Panel, and Omnipathology Solutions Medical Corp. for the Omni Covid–19 Assay by RT–PCR. Both revocations follow the companies' notification that they no longer
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions.” To view the notice, click here.
Biologics
FDA has issued AstraZeneca a complete response letter on its supplemental BLA for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The agency letter is requesting additional clinical data, according to the company. It notes the submission “included data from the OSTRO Phase 3 trial,
FDA Policy/General
Federal Register notice: FDA has determined that GE Healthcare’s MPI DMSA kidney reagent (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met.
Devices
FDA has classified as Class 1 a Baxter Healthcare recall of its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of the devices not sounding alarms for repeated upstream occlusion events. The
Drugs
FDA has extened by three months its review of Incyte’s supplemental NDA for Opzelura (ruxolitinib) cream for treating vitiligo. The new user fee review action target date is 7/18. The review extension is intended to provide FDA needed time to review additional data from ongoing Phase 3 studies
Devices
FDA has issued a warning against using Apyx Medical’s Renuvion/J-Plasma device for certain aesthetic procedures, such as procedures intended to improve the appearance of the skin through dermal resurfacing or skin contraction. The device is cleared for general use of cutting, coagulation, and ablation of soft tissue
Drugs
FDA has approved AstraZeneca’s Lynparza (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Approval was based on data from
FDA Policy/General
Class 2 for Automated Glycemic Controllers 3/11/2022 Federal Register notice: FDA has classified the interoperable automated glycemic controller into medical device Class 2 (special controls). The action is in response to a Tandem Diabetes Care de novo classification request for its Control-IQ Technology. The agency has identified
FDA Policy/General
Ipsen has completed an acquisition of a portfolio of five international consumer healthcare products from Sanofi: Prontalgine, an analgesic for treating moderate to severe pain; Buscopan, an antispasmodic, Suppositoria Glycerini, a laxative; and Mucothiol and Mucodyne, expectorants for cough and flu. Horizon Pharma has agreed to acquire River Vision Development
FDA Policy/General
DEVICES FDA has cleared a Globus Medical 510(k) for the Excelsius GPS, a robotic guidance and navigation system for orthopedic (screw placement applications in spine and orthopedic surgery) and neurosurgical procedures. The device integrates Globus Medical implants and instruments and is compatible with pre-operative computed tomography (CT), intra-
FDA Policy/General
Federal Register notice: FDA has classified the interoperable automated glycemic controller into medical device Class 2 (special controls). The action is in response to a Tandem Diabetes Care de novo classification request for its Control-IQ Technology. The agency has identified it as a device intended to automatically calculate drug
Drugs
FDA has released a five-page Form FDA-483 issued to Leesar Inc. following a 10/2021 inspection of the Fort Myers, FL outsourcing facility. For example, the agency said the firm failed to thoroughly review an out-of-specification potency test result for a lot of vancomycin 1.5g.
Drugs
FDA has granted Allogene Therapeutics a fast track designation for its allogeneic CAR T product (ALLO-316) for treating patients with advanced or metastatic clear cell renal cell carcinoma (RCC) in those who’ve failed standard RCC therapies. “ALLO-316 targets CD70, which is highly expressed in RCC with limited
Devices
FDA has issued a warning against using ACON Biotech Covid-19 tests. The agency says the China-made tests are labeled “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” and packaged in a dark blue box. This test has not been authorized, cleared, or approved for distribution or use
Devices
FDA has issued a rare Section 518(a) notification order to Philips Respironics “requiring the company to notify patients and others of the company’s 6/14/2021 recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk
Drugs
FDA has lifted an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19. The hold was placed in early January, when the agency requested further information on the preparation and administration of IMM-BCP-01 at clinical sites. IMM-BCP-01 is a three-antibody
FDA Policy/General
A Parkland, FL man who was the sales director for Blackstone Labs was sentenced 3/11 to 51 months in prison for conspiring to defraud FDA and conspiring to distribute anabolic steroids. According to a Justice Department release, a jury convicted James Boccuzzi in December for his and the firm’
Drugs
Venatorx Pharmaceuticals says it is planning an NDA submission in the fourth quarter after reporting “positive results” from its pivotal Phase 3 study evaluating cefepime-taniborbactam as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis. The company says that if approved the combination
Drugs
FDA has set 8/4 as the PDUFA target action date for an Acadia Pharmaceuticals resubmitted sNDA for a new indication for its Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The company says it was told by the CDER Division of Psychiatry that it