Biologics
An 8/2-8/12/22 FDA inspection at RenatiLabs in Erlanger, KY, determined that the firm manufactures WJMAX, a product derived from human umbilical cord, for allogeneic use. A just-released 6/1 Warning Letter says the product is distributed directly to doctors throughout the U.S. to administer
FDA Policy/General
Federal Register notice: FDA is announcing the publication of modifications it is making to the list of medical device standards recognized for use in premarket reviews. The publication, “Modifications to the List of Recognized Standards, Recognition List Number: 059” is intended to assist manufacturers who elect to declare conformity with
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Premarket Notification for a New Dietary Ingredient—21 CFR 190.6.” The collection supports agency regulations and guidance on manufacturer or distributor notifications when a new dietary ingredient (NDI) or a dietary supplement that contains the NDI
Drugs
A 1/30-2/8 FDA inspection at the Centaur Pharmaceuticals drug manufacturing facility in Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations in the production of finished drugs. A 7/25 Warning Letter says the specific violations were: * failing to clean, maintain, and, as appropriate
Drugs
FDA is reminding product sponsors that the deadline for the second submission cycle of its Advancing Real-World Evidence (RWE) program is 9/30. For selected sponsors, the program provides an opportunity to meet with staff from CDER, CBER, and the Oncology Center of Excellence, before protocol development or study
Drugs
FDA has published a draft guidance, Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR, with recommendations for applications for these products. Specifically, the document addresses versions of previously approved single-entity (SE) and fixed-combination (FC) antiretroviral (ARV)
FDA Policy/General
FDA is looking to revamp its advisory committees to convene panels to solicit input and discuss issues involving broader scientific topics than the current typical meeting that involves product marketing applications. Speaking at an Alliance for a Stronger FDA online update, FDA chief scientist Namandjé Bumpus said her office is
Drugs
FDA has revised form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigational New Drug Application (IND) to align with new user fee requirements and to make data-quality improvements. To learn more about the specific revisions, click here.
Biologics
The Advanced Medical Technology Association (AdvaMed) says decentralized clinical trials can facilitate diversity in clinical trials. Commenting on an FDA draft guidance on decentralized clinical trials for drugs, biological products, or medical devices, AdvaMed says the document can facilitate recruitment of diverse populations in clinical trials and may help expedite
Drugs
FDA has approved Taiho Oncology’s Lonsurf (trifluridine and tipiracil) with bevacizumab for treating metastatic colorectal cancer (mCRC) patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In 2015, the agency approved single-agent Lonsurf
Devices
FDA has cleared a Becton, Dickinson 510(k) for the BD Respiratory Viral Panel for BD MAX System, a single molecular diagnostic combination test that BD says identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in about two hours. Previously, the test was
Devices
Baxter Healthcare has recalled its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased false alarm reports of upstream occlusion after pump software upgrades. “False upstream occlusion alarms cause interrupted or delayed therapy and
FDA Policy/General
Federal Register notice: FDA has determined that progesterone injection, USP, 50 mg/mL, was not withdrawn due to safety or effectiveness issues. The determination means that the agency can continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. The Actavis
Drugs
FDA has granted fast-track designation to Invectys’ IVS-3001 for treating renal cell cancer. A company statement says the designation was based on data from an IND submission and the potential for meeting the unmet needs of patients with HLA-G positive locally advanced or metastatic clear cell renal
Drugs
Lupin Pharmaceuticals has recalled two lots of Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets 3mg/0.03mg/0.451 mg) due to out-of-specification test results at the 12-month stability time point. According to a recall notice, one lot tested low for ascorbic acid (an inactive ingredient)
Drugs
In an unusual 8/1 “Dear Americans” open letter, FDA commissioner Robert Califf and Drug Enforcement Administration (DEA) administrator Anne Milgram say the current shortage in prescription stimulants is not a problem the two agencies can solve on their own. “We are urging all stakeholders to work together to resolve
Drugs
FDA has granted Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer. Elraglusib is described as a glycogen synthase kinase-3 beta (GSK-3β) inhibitor that targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such
Drugs
A 7/28 Warning Letter cites Sanand, India-based Intas Pharmaceuticals for current good manufacturing practice (CGMP) violations found during an 11/22/22-12/2/22 FDA inspection. The letter says specific violations were: * failure of the firm’s quality control unit to exercise its responsibility to ensure drug
Drugs
A 1/30-2/10 FDA inspection at the Iso-Tex Diagnostics drug manufacturing facility in Alvin, TX, found significant violations of current good drug manufacturing (CGMP) regulations for finished drugs. A 7/20 Warning Letter says specific violations were: * failing to have buildings used in the manufacturing, processing, packing,
Drugs
A 1/19-1/27 FDA inspection at the Baxter Pharmaceuticals India drug manufacturing facility in Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/25 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has cleared a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device — mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. The company says the expanded use now allows physicians to use the device to control all bleeding in cardiac
Drugs
FDA has approved a GSK supplemental BLA for Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by single agent Jemperli for treating adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test. Approval was based on data