Devices
The Neurological Devices Panel of the FDA Medical Devices Advisory Committee met 6/3-4 to discuss and make recommendations related to the classification of six unclassified, preamendments device types. A meeting summary lists the items discussed as classification of: * vapocoolant devices; * acupressure devices; * electro-acupuncture stimulators; * attention task performance
Drugs
FDA has approved a Vertex Pharmaceuticals supplemental NDA for Trikafta (elexacaftor/tezacaftor/ivacaftor) to include children with cystic fibrosis aged 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive
Drugs
FDA and HHS have released a report with policy recommendations to address the vulnerabilities in the nation’s pharmaceutical supply chains. An HHS announcement says the report and its recommendations have been accepted by President Joe Biden. “Last year the American people experienced a widespread and significant shortage of N95
Drugs
Two people who worked for Tellus Clinical Research in Florida pleaded guilty 6/8 in a Florida federal court to participating in a conspiracy to falsify clinical trial data. A Department of Justice statement says that Eduardo Novarro, Miami, FL, a sub-investigator, and Nayade Varona, Port St. Lucie, FL,
FDA Policy/General
In its response to a National Institute of Standards and Technology (NIST) workshop and call for position papers, FDA says NIST and the National Telecommunications and Information Administration should “continue with and enhance their present approaches to the development of standards and guidelines for operational technology security by leveraging experts
Biologics
FDA has approved Pfizer’s Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults aged 18 years and older. The company says the vaccine includes capsular polysaccharide conjugates for the 13 serotypes (1,
Devices
FDA has cleared a CyMedica Orthopedics 510(k) for its IntelliHab for managing knee osteoarthritis pain. The device delivers neuromodulation strengthening therapy to treat pain associated with osteoarthritis. The individualized muscle stimulation is intended to reduce muscle weakness, “while keeping patients proactive in therapy through an intuitive app-driven interface,
Drugs
FDA says its review of a Web site and social media pages maintained by Everything Health LLC, Carnation, WA, determined that the company illegally offers CoronaBox for sale in the U.S. A 5/24 Warning Letter says the product is intended to mitigate, prevent, treat, diagnose, or cure Covid-
Drugs
RVL Pharmaceuticals is petitioning FDA to require ANDA applicants and section 505(b)(2) applicants who seek “A” ratings to use appropriate methods to establish that their proposed products are bioequivalent and therapeutically equivalent to Upneeq (oxymetazoline HCl ophthalmic solution) 0/1%. The company’s 6/2 petition asks the
Drugs
FDA has informed Incyte that it has extended the review period for the company’s sNDA for Jakafi (ruxolitinib) for treating adult and pediatric patients age 12 and older with steroid-refractory chronic graft-versus-host disease. The new PDUFA target action date is 9/22, the agency says. FDA
Drugs
OptiNose is petitioning FDA to take specific actions regarding any ANDA or section 505(b)(2) application that references or relies upon the company’s Xhance (fluticasone propionate) nasal spray. A 5/31 petition asks that the agency: * not approve an ANDA referencing Xhance unless the applicant demonstrates bioequivalence and
Drugs
[Report by Jim Dickinson and David McFarland] FDA’s 6/7 accelerated approval for Biogen’s Alzheimer’s drug Aduhelm (aducanumab-avwa) has provoked an immediate uproar among stakeholders over whether it undermines the agency’s coveted gold standard of scientific objectivity. Striking a positive lead from the legal constituency,
Drugs
FDA says it has decided not to accept a Verily Life Sciences 1/25 Letter of Intent for the Virtual Motor Exam for Parkinson’s disease, Part 3 Estimator, as measured by the Verily Study Watch. An agency determination letter says the letter proposed assessment of motor symptom severity in
Biologics
FDA says Aziyo Biologics has recalled one lot of its FiberCel Fiber Viable Bone Matrix following a customer complaint from one hospital that initially reported post-surgical infection in seven of the 23 patients who received FiberCel from the specified donor lot. Four of the patients tested positive for tuberculosis,
Drugs
FDA has granted BerGenBio ASA a fast track designation for bemcentinib in combination with an anti-PD-(L)1 agent for treating patients with AXL-positive advanced/metastatic non-small cell lung cancer. The designation has been granted for patients without actionable mutations, with disease progression on or after treatment
Devices
FDA has cleared an AngioDynamics 510(k) for the AlphaVac Mechanical Thrombectomy System, an off-circuit, multi-purpose mechanical aspiration thrombectomy device for the non-surgical removal of thrombi or emboli from the vasculature. The device combines two of AngioDynamics’ proprietary technologies: a new mechanical aspiration handle and its self-
FDA Policy/General
Federal Register notice: FDA has determined that Hospira’s Quelicin Preservative Free (succinylcholine chloride) injection, 20mg/mL, 50mg/mL and 100mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements
Devices
FDA has announced a 9/17 virtual public workshop entitled “Spinal Device Clinical Review.” The workshop is intended to clarify FDA’s approach to clinical review of spinal devices falling under 21 CFR Part 888. It will also address the major elements that the agency assesses in its review of
FDA Policy/General
Federal Register notice: FDA has determined that Boehringer Ingelheim Pharmaceuticals’ Atrovent (ipratropium bromide) metered spray 0.021 mcg and 0.042 mcg were not withdrawn from sale due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that refer to the products as
Drugs
FDA has granted accelerated approval for Biogen’s Aduhelm (aducanumab), the first drug since 2003 approved for treating Alzheimer’s. Approval was based on the drug’s effect on a surrogate endpoint — reducing amyloid beta plaque— and a post-approval trial is required to verify that the drug provides the
Drugs
FDA has approved a Medtronic PMA for the SenSight Directional Lead System used for deep brain stimulation (DBS) therapy. The company says the device is designed for treating some symptoms associated with movement disorders like Parkinson's disease, dystonia and essential tremor, and medically refractory epilepsy. DBS comprises a
Drugs
FDA has approved an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) injection and its use in treating patients aged one month and older with paroxysmal nocturnal hemoglobinuria (PNH). The a rare, life-threatening blood disease is characterized by red blood cell destruction, anemia, blood clots, and impaired bone marrow function.