Drugs
The CDER Office of Generic Drugs (OGD) has revised its scientific priorities as part of its user fee performance goals through 2022. For example, a research priority initiative to develop better methods for evaluating opioid product abuse deterrence that was included in the FY 2020 priorities was removed from the
Biologics
FDA has approved an Amgen supplemental BLA for Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapies for patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). Repatha works by recto reducing low-density lipoprotein
Drugs
FDA has granted Genmab and Seagen accelerated approval for their BLA for Tivdak (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) for treating adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on data from the innovaTV 204 clinical trial that
Drugs
FDA has extended by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human growth hormone for treating growth hormone deficiency in pediatric patients. The goal date was extended to give the agency more time to review a Pfizer submission of
FDA Policy/General
Federal Register notice: FDA has announced a 12/8 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Reata Pharmaceuticals NDA for its Nrf2 activator bardoxolone methyl capsules, indicated for slowing chronic kidney disease progression caused by Alport syndrome in patients 12 years of age
Biologics
(Update 9/24): Less than 24 hours after FDA amended the emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine to allow a booster dose for certain adults, the Centers for Disease Control and Prevention (CDC) 9/23 narrowed the recommended shots to exclude front-line and other
Devices
FDA says it has revised the authorizations of certain molecular, antigen, and serological tests for Covid-19 to help ensure that the tests’ performance is not affected by emerging SARS-CoV-2 viral mutations. An agency announcement says the revisions require additional conditions of authorization concerning viral mutations. FDA says
Drugs
Federal Register notice: FDA has announced a 12/2 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to hear certain updates on NDAs approved under accelerated approval that have not verified clinical benefit. Products being discussed are: (1) Secura Bio’s Farydak (panobinostat) capsules, indicated in combination with bortezomib
Devices
Cordis has recalled its Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the bands to move or dislodge during procedures. The movement can happen where the catheter is trapped between another device and the vessel wall, according to a recall notice. Such movement
Drugs
Emery Pharma is asking FDA to issue a regulation, revise industry guidance, and request a recall and suspend sales of vitamin B6 (pyridoxine) from the U.S. market. A 9/20 petition says mega doses (50-500 mg) of vitamin B6 are widely available over-the-counter and online. When
Drugs
FDA has released an FDA-483 issued following a 7/2-8/12 inspection at Prescription Labs Inc., Houston, TX, a producer of sterile and non-sterile drugs doing business as Greenpark. The 10 inspection observations were: * personnel engaged in aseptic processing were observed with exposed skin; * the firm released
Drugs
IntegraDose Compounding Services is recalling nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefazolin 3g in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance. The sterility issue was traced to a newly installed biologic
Devices
Washington Legal Foundation (WLF) says the California Court of Appeals should reverse a trial court decision that imposed $344 million in civil penalties on Ethicon for disseminating what WLF says is fully protected scientific speech. A WLF statement says the trial court found that every communication the defendants made about
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site, social media pages, and other online sources for Genesis Medical Center, Irvine, CA, determined that the firm markets what it describes as a “stem cell therapy” or “biological therapy” product derived from adipose tissue to
Devices
AdvaMed says it supports FDA efforts to clarify which activities performed on medical devices are remanufacturing or servicing. In a 9/22 comment on an agency draft guidance, the association says that much device servicing performed by third-party servicing entities is actually remanufacturing and subject to FDA remanufacturing requirements.
Drugs
FDA has approved Baxter’s premix norepinephrine bitartrate in 5% dextrose injection, indicated for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure). The ready-to-use formulation and is available in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry #253 entitled Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products. The document is intended to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) with recommendations for meeting
FDA Policy/General
Federal Register notice: FDA is announcing the availability of a draft guidance for industry #254 entitled Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products. The document emphasizes that donor eligibility is a critical component of current good manufacturing practices when manufacturing such products. It says a
Devices
FDA has announced a 12/3 virtual public workshop entitled “Orthopedic Device-Related Infections II Workshop.” This will be the second workshop sponsored by the agency to provide information about infections related to orthopedic devices and to seek feedback on current and potential future strategies for protecting and promoting public
Drugs
FDA says a review of records submitted by Furley Bioextracts SDN BHD, Selangor, Malaysia, a manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, along with a misbranded unapproved new drug. A 9/13 Warning Letter says specific CGMP
Drugs
FDA says its review of materials submitted by Laboratorio Pharma Internation SRL, Tegucigalpa, Honduras, a manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/15 Warning Letter also says the firm’s Gelazul topical analgesic is a
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