Drugs
The DC federal court has granted summary judgment to seven compounding pharmacies throughout the U.S. that challenged an FDA 10/2020 Final Standard Memorandum of Understanding (MOU) establishing an agreement between state boards of pharmacy and the agency. The agreement would require those boards that sign it to identify
Drugs
In its Biosimilar User Fee Act (BsUFA) 3 goal letter for FY 2023-2027, FDA commits to responding to 90% of original biosimilar product application submissions within 10 months of the 60-day filing date and 90% of resubmitted original biosimilar product applications within six months of the receipt date.
Devices
FDA, which partnered with ECRI, an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation, has published the first four safety summaries. The documents cover magnesium, polypropylene, polyurethane, and siloxanes. The review for
Drugs
FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) for treating adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. Approval was based on
Drugs
FDA has approved an Incyte supplemental NDA for Jakafi (ruxolitinib) for treating chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Approval is based on data from the Phase 3 REACH3 study of Jakafi
Devices
The Medical Imaging & Technology Alliance (MITA) says it is concerned that an FDA draft guidance on remanufacturing of medical devices will not achieve its intended outcome given that the agency is relying on third-party servicers and independent service organizations (ISOs) to comply with the guidance. A MITA 9/
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a B. Braun Medical ANDA for 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection in Excel plastic container after the company requested that it be withdrawn. Hydroxyethyl starch products are approved for treating hypovolemia (low blood volume). To
FDA Policy/General
Federal Register notice: FDA has announced an 11/2 virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act for fiscal years 2023 through 2027. To view the notice, click here.
Devices
FDA has authorized the de novo marketing of Paige AI’s Paige Prostate software that is intended to assist pathologists in detecting areas that are suspicious for cancer as an adjunct to reviewing digitally-scanned slide images from prostate biopsies. The artificial intelligence (AI)-based software is designed to identify
Biologics
FDA has told Reykjavik, Iceland-based Alvotech that it is deferring action on its BLA for AVT02, the company’s proposed biosimilar of AbbVie’s Humira (adalimumab) Humira, until manufacturing facility inspections/assessments can be completed. “The FDA can defer action when no deficiencies have been identified and the application
Drugs
Attorneys Charles Raver and James Valentine (Hyman, Phelps & McNamara) say they were excited by many of the items included in the FDA PDUFA 7 goals letter for 2023-2027 while recognizing that the real success will come from how the agency implements its goals. “From new initiatives to facilitate
Drugs
Researchers from FDA and Stanford University say the agency has no mechanism to find or tradition to cite similar cases when weighing evidence for drug approvals, resulting in “standalone, bespoke decisions.” Writing in the Annals of Internal Medicines, the researchers say that as a result, FDA’s decisions show highly
Drugs
FDA and Health Canada have announced a 10/8 regional public consultation on recent International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) activities and future topics. Such consultation meetings are held prior to each bi-annual ICH meeting to seek input on current and future
Drugs
FDA is telling NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synchron Research Services, located in Ahmedabad, Gujarat, India, and Panexcell Clinical Lab, Navi Mumbai, India, are not acceptable because of data integrity concerns. An agency notice says the studies must be repeated. The notice says the
Drugs
Johnson & Johnson says new data show increased protection against Covid-19 when a booster shot of its vaccine is administered, adding that the vaccine’s safety profile remained consistent after the booster shot. The company says a real-world evidence study for its vaccine demonstrated 79% effectiveness for Covid-
Drugs
FDA says Web sites and social media pages maintained by the Fibromyalgia Treatment Group (FTG), Eagle, ID, promote the sale of several products that are unapproved new drugs. A just-released 8/26 Warning Letter gives claims made for the products and says they are not generally recognized as safe
Drugs
FDA has approved a Samsung Bioepis and Biogen BLA for BYOOVIZ (ranibizumab-nuna), the first biosimilar version of Genentech’s Lucentis, which is indicated for treating neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Ranibizumab is an anti-vascular endothelial growth factor
FDA Policy/General
Federal Register notice: FDA is making available on its Web site certain final administrative orders, including for over-the-counter (OTC) drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act. To access the final orders, go to the OTC Monographs@FDA
Devices
FDA has issued an alert about the potential for false positive results with Abbott Molecular’s Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. False positive results may be related to current mixing parameters of the polymerase chain reaction mixture that may result
Biologics
AbbVie has submitted a BLA supplement for Skyrizi (risankizumab-rzaa) (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy) for treating patients 16 years and older with moderate to severe Crohn’s disease. The submission is based on data from three Phase 3 studies — ADVANCE, MOTIVATE and
Drugs
FDA has released a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence. The document provides FDA’s current thinking on quality-related scientific and regulatory topics that appear frequently in generic drug controlled correspondence submissions to CDER’s Office of Pharmaceutical Quality (OPQ) regarding chemistry, manufacturing, and
Drugs
Medtronic’s Micro Therapeutics unit (dba ev3 Neurovascular) has begun a Class 1 recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to the risk that its delivery system wire and tubes could fracture and break off inside a patient. Attempts to retrieve