Drugs
FDA has approved Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz) 100 mg/mL, a new dosing formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (HUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric patients. The new formulation was designed to reduce average annual
Devices
FDA has cleared a GE Healthcare 510(k) for the Ultra Edition package on its Vivid cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that helps clinicians acquire faster, more repeatable exams consistently. The device features AI Auto Measure Spectrum Recognition which can detect the appropriate
FDA Policy/General
Final Guide on Biological Deviation Reporting Federal Register notice: FDA makes available a final guidance entitled “Biological Product Deviation Reporting for Blood and Plasma Establishments.” 10/9/2020 Info Collection on Device Inspection Feedback Federal Register notice: FDA sends to OMB an proposed information collection entitled “Requests for Nonbinding Feedback
FDA Policy/General
Mylan has signed an agreement with the Medicines Patent Pool (MPP) to expand access to chronic hepatitis C medicines in developing countries. The agreement licenses Mylan to produce and market a generic version of Bristol-Myers Squibb’s Daklinza (daclatasvir) Tablets, 30 mg and 60 mg, for distribution in 112
Drugs
FDA has accepted for review a Foresee Pharmaceuticals 505(b)(2) NDA for Camcevi 42mg, a ready-to-use six-month depot formulation of leuprolide mesylate, indicated for treating advanced prostate carcinoma patients. The agency has set a user fee review action target date of 5/27/2021. The submission
Devices
FDA has granted Beckman Coulter an emergency use authorization for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay. The test detects antibodies that recognize the receptor binding domain of the spike protein which the Covid-19 virus uses to enter the human host cells, the company says. The qualitative
Drugs
FDA has issued a revised Manual of Policies and Procedures (MAPP) on ANDA Suitability Petitions to clarify certain issues and include minor updates to the process and organization. The MAPP establishes the policies and procedures for CDER’s Office of Generic Drugs to respond to suitability petitions submitted to it
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 13 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of nine ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
Drugs
Intercept Pharmaceuticals says FDA has told the company that it is evaluating a “newly identified safety signal regarding liver disorder for Ocaliva which the FDA classified as a potential risk.” The signal was noticed in May during the agency's routine safety surveillance, Intercept says in a financial report.
Drugs
FDA has sent Griffo Botanicals (Petaluma, CA) a Warning Letter after reviewing the company’s Web site and social media sites and determining that its herbal tincture products are unapproved new drugs because they are being marketed to mitigate, prevent, treat, diagnose, or cure Covid-19. The agency letter took
FDA Policy/General
The Government Accountability Office (GAO) says FDA should take additional steps to strengthen efforts to provide effective laboratory safety oversight. A GAO report says it examined FDA efforts since 2016 to improve safety in its laboratories that work with hazardous biological agents. An initial GAO report in 2016 made five
FDA Policy/General
Federal Register notice: FDA is correcting a notice that published in the 9/21 Federal Register announcing the withdrawal of a final guidance entitled Investigational COVID–19 Convalescent Plasma. The docket number is being corrected for the guidance that was withdrawn. To view the notice, click here.
Drugs
An online post from Govzilla, data intelligence consultants, gives tips for regulated companies on how to talk with FDA officials and how to listen when FDA officials talk to them. The post is based on information presented at a 9/2019 Regulatory Affairs Professionals Society meeting by former FDA team
Drugs
FDA has granted X4 Pharmaceuticals a Fast Track Designation for mavorixafor for treating adult patients with WHIM (Warts, Hypogammaglobulinemia Infections and Myelokathexis) syndrome, an inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company describes mavorixafor as a small molecule antagonist of chemokine receptor CXCR4,
Drugs
FDA has awarded six new clinical trial research grants to principal investigators from academia and industry worth $16 million over the next four years. The grants, awarded through the Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases, an agency announcement says. The agency
Devices
CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel told the agency’s weekly virtual town hall session 10/7 that FDA will no longer review Covid emergency use authorization (EUA) submissions for lab-developed tests. Modern Healthcare reports that Stenzel said the change is consistent with
Drugs
FDA has granted Y-mAbs Therapeutics an orphan drug designation and rare pediatric disease designation for its antibody nivatrotamab and its use in treating neuroblastoma. The humanized bispecific anti-GD2 antibody is currently in Phase 1 clinical development in collaboration with Memorial Sloan Kettering Cancer Center in patients with relapsed/
Devices
FDA has given GenMark Diagnostics an Emergency Use Authorization for its ePlex Respiratory Pathogen Panel 2. The test provides in less than two hours results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including Covid-19, flu, bronchitis and the common cold, according
Drugs
Regeneron says it has submitted to FDA an emergency use authorization (EUA) for its experimental antibody cocktail that president Trump has taken for his coronavirus infection and already the president is applying political pressure on FDA to act fast and calling the therapy a cure. Regeneron’s filing comes on
Drugs
Lilly says it has asked FDA for an emergency use authorization (EUA) for its bamlanivimab neutralizing IgG1 monoclonal antibody as monotherapy in higher-risk patients who have recently been diagnosed with mild-to-moderate Covid-19. The company says it expects to submit an EUA request for combination therapy with
FDA Policy/General
FDA chief counsel Stacy Cline Amin says the Covid-19 emergency has offered the agency an opportunity to set a new legal precedent that will “inspire a new era of compliance and enforcement for FDA.” Delivering the annual chief counsel’s address at the Food and Drug Law Institute’s