Biologics
FDA has issued Boise, ID-based Smart Surgical, dba Burst Biologics, a Warning Letter after an inspection last year determined it is marketing unapproved products derived from human umbilical cord blood (BioBurst Fluid and BioBurst Rejuv) for allogeneic use. The inspection also cited significant GMP deviations and current good tissue
Devices
FDA has cleared a Teleflex expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous coronary interventions (CTO PCI). CTOs are complete blockages in coronary arteries that result in profound regional reduction of coronary blood flow (ischemia), according to the company. Devices receiving
Drugs
FDA has approved a Sage Chemical ANDA for the first generic version of Mylan’s Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomobility “off” episodes (end-of-dose wearing off and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease. FDA notes that the approval is for Sage’
Devices
Speaking during a 2/22 online presentation sponsored by Friends of Cancer Research, Reps. Donna DeGette (D-CO) and Larry Buschon (R-IN) stressed their determination to see approval of the VALID Act (Verifying Accurate Leading Edge IVCT [in vitro clinical test] Development Act of 2021 during the current Congress.
Drugs
FDA has extended by three months its review of a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) for treating obesity and control of hunger in adult and pediatric patients six years of age and older with Bardet-Biedl Syndrome (BBS) or Alström syndrome. The new user fee review action date
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Exemptions From Substantial Equivalence Requirements for Tobacco Products” (OMB Control Number 0910-0684). FDA’s regulations establish a pathway for manufacturers to request exemptions from substantial equivalence requirements for tobacco products that are modified by adding or
Drugs
FDA has tightened its emergency use authorization for GlaxoSmithKline/Vir Biotech’s sotrovimab to restrict its use in some cases. The monoclonal antibody is a treatment for mild-to-moderate Covid-19 in adults and children age 12 and older with positive results of direct SARS-CoV-2 viral testing
Devices
FDA says the 12/22/21 Arrow International recall of its Arrow-Trerotola percutaneous thrombolytic device is Class 1. An agency notice says the company recalled 24,895 units manufactured between 1/1/20 and 12/31/21 and distributed between 2/1/20 and 12/31/21. The device
Drugs
FDA has granted Boehringer Ingelheim Pharmaceuticals a breakthrough therapy designation for its investigational therapy BI 1015550 and its use in treating idiopathic pulmonary fibrosis. The company says the oral phosphodiesterase 4B inhibitor has the potential to address both pulmonary fibrosis, which is the scarring of lung tissue, and inflammation associated
Drugs
Apricus Biosciences says FDA requests for a new formulation and two new Phase 3 efficacy trials for its Vitaros (alprostadil, DDAIP.HCl) topical cream to treat erectile dysfunction exceed the company’s existing resources and ability to raise capital. In a statement on its Vitaros end-of-review meeting with
Drugs
FDA has released the FDA-483 issued following a 9/23-10/7/21 inspection at Denver Solutions, an Englewood, CO, outsourcing facility. The seven inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Drugs
FDA has approved a broader indication for Boehringer Ingelheim’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. An agency notice says the drug received priority review for this new indication. Jardiance was originally approved by the agency in 2014 as a
Devices
FDA has cleared a Viz.ai 510(k) for the Viz Aneurysm module and its use on the Viz Intelligent Care Coordination Platform for detecting suspected cerebral aneurysms from computerized tomography angiograms (CTAs). The artificial intelligence platform is currently used to coordinate care across several clinical applications, including ischemic and
Drugs
FDA has extended its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil), indicated for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, after receiving an information request letter from the agency. According to the company, FDA requested additional information on the pulmonary
FDA Policy/General
Federal Register notice: FDA is announcing a 3/22 virtual public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA),” and an opportunity for public comment. The topics to be discussed are the final assessment and public stakeholder views
FDA Policy/General
CDER Office of Prescription Drug Promotion senior social science analyst and research team lead Katherine Aikin says her group investigates how healthcare providers and patients perceive medical product information about prescription drugs and make subsequent treatment decisions. Interviewed for an online post, Aikin says her team usually has about 20
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) 2021 annual report says that in response to a White House call for strategies to improve medicine supply chain transparency and incentivize resilience, it is working on an emerging technology program, a framework for regulatory advanced manufacturing evaluation, and quality management maturity ratings.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the Covid-19 Pandemic.” The agency says that during the pandemic there has been a significant reduction in the supply of nonhuman primates available for conducting toxicology studies for
Devices
AdvaMed says it appreciates FDA efforts to develop proposed transition plans dealing with medical devices issued emergency use authorizations during the Covid-19 emergency and medical devices under Covid-19 enforcement policies. The company’s comment letter thanks FDA “for its commitment to help provide a clear transition process to
Drugs
FDA has again issued Mallinckrodt a Complete Response Letter on its NDA for terlipressin to treat adults with hepatorenal syndrome (HRS), an acute and life-threatening condition involving rapid reduction in kidney function. “Within the last two weeks, it became necessary to identify a new packaging and labeling manufacturing facility
Drugs
FDA has released a 28-page FDA-483 with 13 observations from a 9/20-11/30/21 inspection at Edge Pharma, a Colchester, VT, outsourcing facility. The inspection observations were: * buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good
Biologics
Sanofi and GlaxoSmithKline say they will submit data to FDA supporting their request for regulatory authorization for a Covid-19 vaccine. The companies say that in a Phase 3 trial, two doses of the vaccine demonstrated 100% efficacy against severe Covid-19 disease and hospitalizations, 75% efficacy against moderate or