FDA Policy/General
Federal Register notice: FDA has announced the revocation of an Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Covid–19 IgM/IgG System. The EUA was revoked based on three evaluations that demonstrated its performance may be both inconsistent and lower than that described in the request
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).” FDA developed the draft to propose select updates to certain sections of the existing FDA guidance document
FDA Policy/General
Federal Register notice: FDA has announced its support for the current version of Clinical Data Interchange Standards Consortium Standard for the Exchange of Nonclinical Data and an update to the FDA Data Standards Catalog for submitting nonclinical data in medical product applications. The agency notes that the update does not
Devices
FDA has published a guidance, Clinical Investigations for Prostate Tissue Ablation Devices, with recommendations for complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation. The document also makes recommendations for collecting clinical data to support marketing submissions for new
FDA Policy/General
Federal Register notice: FDA is making information available on the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devices related to the Covid–19 public health emergency. These EUAs contain, among other things, conditions on the emergency use of the authorized products. To view the notice, click
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Kegan Wellness, Ahmedabad, India (7/13): FDA recently reviewed the firm’s Internet address and social media sites and determined that vitamin
Drugs
FDA commissioner Stephen Hahn says the cross-Center Coronavirus Treatment Acceleration Program (CTAP), involving CBER and CDER staff, has reviewed more than 230 trials for potential Covid-19 treatment therapies. In a CTAP update report, Hahn also says there now are more than 510 Covid drug developmemt programs in planning
Drugs
FDA has issued a complete response letter seeking additional chemistry, manufacturing, and controls information from Verrica Pharmaceuticals for its NDA for VP-102, the company’s investigational proprietary drug/device combination to treat molluscum contagiosum. A company notice says the agency did not identify any clinical deficiencies. Verrica says it
Drugs
TriNetX has signed an agreement with the FDA Sentinel program under which the agency is licensing the full TriNetX analytics suite that provides direct access to de-identified real-world data in the TriNetX U.S. network for the FDA Office of Surveillance and Epidemiology and the Sentinel operations center.
FDA Policy/General
FDA has published four draft guidances to help facilitate the development of new animal drug products. Center for Veterinary Medicine director Steven Solomon says the publication “fulfills part of FDA’s Animal Drug and Animal Generic Drug User Fee Amendments of 2018 to issue guidance that assists animal drug manufacturers
Drugs
FDA has issued CytoDyn a refusal to file letter on its BLA for leronlimab (PRO 140), a CCR5 antagonist used in combination therapy with highly active antiretroviral therapy for highly treatment-experienced HIV patients. FDA’s letter said the BLA does not contain certain information needed to complete a substantive
Drugs
FDA has just released the FDA-483 issued following a 1/14-2/8/19 agency inspection at RC Outsourcing, Lowellville, OH. The eight inspection observations were: * failing to follow written production and process control procedures in the execution of production and process control functions; * failing to have a written
Devices
FDA has granted Revamp Medical a breakthrough device designation for its Doraya percutaneous device for treating acute heart failure (AHF). The temporary catheter, placed in the inferior vena cava below the renal veins, provides partial adjustable flow for up to 12 hours. “The device flow regulator mechanism is designed to
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.” FDA says that exclusion of patients with HIV, HBV, or HCV infections from cancer clinical trials remains common in most investigational drug studies.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Cartiva, a device used for treating patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus), which is manufactured by Cartiva Inc. The regulatory review period was determined to be 2,407
Drugs
Genentech says the Phase 3 IMagyn050 study showed that the addition of Tecentriq (atezolizumab) to Avastin (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival for front-line treatment of women with newly-diagnosed advanced-stage ovarian cancer. The company says safety data indicated that
Drugs
FDA reviewers are raising safety concerns about a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory Committee meeting 7/14 for the proposed indication for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38
Drugs
Sens. Marco Rubio (R-FL) and Elizabeth Warren (D-MA) have introduced legislation directing the Federal Trade Commission and the Treasury Secretary to study the United States’ over-reliance on foreign countries and the impact of foreign direct investment on the U.S. pharmaceutical industry and DNA analysis industries. A
Drugs
FDA has published a guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, with information on how the agency defines the types of changes to an approved risk evaluation and mitigation strategy (REMS), how application holders should submit changes to an approved REMS, and how FDA will process submissions from
Drugs
FDA says it is planning to begin high-priority domestic inspections (on-site surveillance) for medical products and other regulated products during the week of 7/20. Resuming domestic inspections will depend on the data about the “virus’ trajectory in a given state and locality and the rules and guidelines
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Toyama Chemical Co.’s , Xepi (ozenoxacin), indicated for topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients two months of age and older. The regulatory review period was
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” The document encourages designing clinical trials that include such patients and including this information in the labeling. “Evidence of clinical efficacy in the subset of patients with brain metastases compared to available