Drugs
FDA says the expiration date for 42 lots of Octapharma Produktionsges’ Cutaquig immune globulin, subcutaneous (human)-hipp 16.5% solution can be extended from 24 to 36 months when stored at a cooler temperature under conditions specified in the agency notice. FDA says the 42 lots covered by the new
Devices
FDA has cleared a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its NeuroStar Advanced Therapy System. “The new protocol arms physicians with the ability to now offer a third FDA-cleared treatment protocol with NeuroStar Advanced Therapy, a non-drug,
Devices
FDA has recognized the ANSI National Accreditation Board (ANAB) as an accreditation body for the Accreditation Scheme for Community Assessment (ASCA) pilot. ANSI (the American National Standards Institute) says the agency recognition allows ANAB to accredit testing laboratories to perform premarket testing for medical device companies. The ASCA pilot relies
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: AuroLife Pharma, Dayton, NJ (10/16): FDA inspected the firm 1/13-2/12 and found significant GMP violations for finished pharmaceuticals.
FDA Policy/General
Three Covington & Burling attorneys say in an online post the incoming administration of President-elect Joe Biden is likely to have these priorities at FDA: * science-based decision-making to highlight career scientific staff and rebuild what is seen as an erosion of public trust in federal health agencies;
FDA Policy/General
FDA Office of Trade, Mutual Recognition, and International Arrangements senior advisors Anne Kirchner and Joseph Rieras say the United States-Mexico-Canada Agreement (USMCA) that took effect 7/1 “aligns regulatory standards with agency practices, betters the quality of products available to American consumers, and levels the playing field for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives during drug development as well as determining how
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Elemental Impurities in Animal Drug Products — Questions and Answers.” The document provides recommendations to sponsors on the control of elemental impurities in animal drug products, including all dosage forms and routes of administration. To view the notice, click here.
Drugs
HHS is sidestepping FDA to terminate the agency’s unapproved drug initiative (UDI) as part of the Trump administration’s efforts to reduce prescription drug costs. UDI is an FDA program launched through guidance documents issued in 2006 and 2011. The program aimed to legalize marketed drugs that lack FDA
Drugs
AstraZeneca says it is preparing an emergency use authorization request for its investigational vaccine AZD1222 after an interim analysis showed that the vaccine was highly effective in preventing Covid-19 and no hospitalizations or severe disease cases were reported in participants receiving the vaccine. There were a total of 131
Drugs
FDA has launched its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communication with the agency and to simplify orphan drug designation submissions. “This important initiative is part of broader technology modernization efforts at the FDA to develop a more connected information technology system,
Devices
FDA has released a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligence and machine learning (AI/ML) in medical devices. The transcript notes the committee discussed the composition of the datasets on which the software “learns,” components of the
Drugs
FDA has given expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu. Xofluza was approved in 2018 in a tablet formulation for treating uncomplicated flu in patients
Biologics
FDA has accepted for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease
FDA Policy/General
Guide on Drugs for Cytomegalovirus in Transplants Federal Register notice: FDA makes available a final guidance on developing drugs for cytomegalovirus in transplantation. 11/20/2020 Guide on Posterior Cervical Screw Classification Federal Register notice: FDA makes available a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity
Drugs
Mallinckrodt has agreed to acquire U.S.-based Ocera Therapeutics, a clinical-stage biopharmaceutical company in a deal valued at about $117 million. The transaction gives Mallinckrodt Ocera’s developmental product OCR-002, an ammonia scavenger currently being studied to treat hepatic encephalopathy, a neuropsychiatric syndrome that is associated with
Drugs
Federal Register notice: FDA has made available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. The document is intended to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009.
FDA Policy/General
Federal Register notice: FDA is announcing the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in Combination Drug Regimens. The document describes the agency’s current recommendations on including relevant information in labeling for oncology drugs approved for use in combination drug regimens, including important consideration
Drugs
Johnson & Johnson (J&J) subsidiary Medical Device Business Services has agreed to pay $10 million to settle allegations under the False Claims Act that former J&J subsidiary Therakos promoted Uvar XTS and Cellex extracorporeal photopheresis systems for unapproved uses in pediatric patients between 2006 and 2012.
FDA Policy/General
Federal Register notice: FDA has updated its ongoing listing of issued and reissued Emergency Use Authorizations (EUAs) for medical devices related to the Covid–19 public health emergency. The authorizations contain, among other things, conditions on the emergency use of the EUA products. To view the notice, click here.
Drugs
FDA has issued a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs). It discusses when drug developers should conduct
Biologics
Pfizer and BioNTech have submitted an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 data showing a vaccine efficacy rate of 95%. The latest analysis is based on 170 Covid cases, of which 162 were observed in the placebo group versus eight in