Drugs
FDA says its review of records submitted by Natural Beauty Care Pty Ltd, a Victoria, Australia, manufacturer of over-the-counter drug products, revealed significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released Warning Letter says specific violations were: * failing to have for each
Biologics
Moderna has completed a rolling BLA and requested a priority review for the submission seeking full licensure of its Covid-19 vaccine for use in individuals 18 years of age and older. The vaccine was granted an emergency use authorization by FDA 12/18/2020. The completed submission includes clinical
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” (OMB Control Number 0910-0581). The collection supports agency regulations and associated guidance requiring sponsors to monitor studies evaluating new drugs, biologics, and devices. Data monitoring committees advise
FDA Policy/General
Federal Register notice: FDA has announced a 9/30 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs in the CBER’s Laboratory of Bacterial Polysaccharides. They will also make recommendations on selecting strains to be included in the
Devices
FDA has classified as Class 1 a Bio-Medical Equipment Service Co. recall of the Alaris Infusion Pump Module Model 8100 pump bezel assembly and Alaris infusion pumps repaired with the bezel assembly due to the potential for the bezel components to crack or separate. The separation of one or
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) updated 8/6 its Code on Interactions with Healthcare Professionals, to take effect 1/1/22. Attorneys McKenzie Cato and Alan Kirschenbaum (Hyman, Phelps & McNamara) write in their FDA Law Blog that the latest changes are primarily focused on speaker programs, including
Devices
FDA has approved a Medtronic PMA for its next-generation, self-expanding transcatheter aortic valve replacement (TAVR) system — the Evolut FX TAVR system. The device is designed to enhance ease-of-use and provide greater precision and control throughout the procedure, the company says. It is equipped with gold markers
Drugs
FDA has sent a Warning Letter to Mahita, LLC (Suwanee, GA) after determining that the firm was marketing unapproved and misbranded products related to Covid-19. The letter says its products (e.g., Pantanjali Coronil Kit) are marketed on Facebook and Amazon as a treatment for and prevention against Covid-
Devices
FDA has granted a de novo authorization to Siemens Healthineers for its Enhanced Liver Fibrosis (ELF) Test and its use with the Advia Centaur XP Immunoassay System to provide a simple numeric score that is automatically generated via an algorithm. The test is intended to be used to improve patient
Drugs
FDA has released the FDA-483 issued following an 8/2-8/12 agency inspection at the Aurobindo Pharma Unit 1 active pharmaceutical ingredient manufacturing facility in Doultabad, Telangana, India. The FDA-483 lists these seven inspection observations: * systems for evaluating and qualifying critical material suppliers are inadequate; * inadequate sampling
Drugs
FDA has approved an expanded peripheral artery disease (PAD) indication for Janssen’s Xarelto (rivaroxaban) vascular dose to include patients following recent lower extremity revascularization (LER) due to symptomatic PAD. Janssen says the approval is based on data from the Phase 3 VOYAGER PAD study. With the approval, it says,
Drugs
FDA has released the FDA-483 issued following a 3/2-3/12 inspection at Jubilant Generics, Hardiwar, Uttarakhand, India. Specific violations listed in the FDA-483 are: * · equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety,
Drugs
FDA says CDER researchers have found three process steps to be important for promoting viral clearance during continuous manufacturing of therapeutic proteins. The researchers’ work follows their work to better understand how to remove viral particles during batch manufacturing of protein biologics using chromatographic, chemical inactivation, and filtration steps. An
Drugs
Six senators are asking FDA for information on its work with McKinsey & Company and any potential conflicts of interest that may have arisen while the consulting firm was working for both FDA and opioid manufacturers such as Purdue Pharma. The 8/23 letter was signed by Sens. Edward Markey
Drugs
An FDA 2/15-2/25 inspection at Toyobo, Co., Shiga, Japan, found violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/19 Warning Letter says the specific violation was failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its
FDA Policy/General
Federal Register notice: FDA has updated its listing of product-specific draft and revised draft guidances that provide recommendations on the design of bioequivalence studies to support ANDA submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/28 virtual public meeting entitled “Reauthorization of the Prescription Drug User Fee Act.” The meeting is intended to discuss proposed recommendations for reauthorizing the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027. The current legislative authority for PDUFA
Devices
Cardinal Health has recalled (Class 1) its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalpel N11 contained in the tray. The scalpel has a permanent locking feature that will not allow a clinician to unlock the scalpel once they have closed the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The document provides recommendations about bioequivalence information in ANDAs and ANDA supplements. To view the notice, click here.
Drugs
The Biotechnology Innovation Organization (BIO) is urging FDA to develop additional and broader guidance on patient-reported outcomes. In just-posted comments to the agency on a draft guidance entitled Core Patient-Reported Outcomes (PROs) in Cancer Clinical Trials, BIO said many of the concepts can and should be utilized
Drugs
AstraZeneca’s Alexion drug unit is discontinuing its CHAMPION-ALS Phase 3 clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis due to lack of efficacy. The decision is based on the recommendation of the trial’s independent data monitoring committee after it reviewed data from a pre-
Devices
Cardinal Health has recalled three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the syringe after a health care provider has pushed out air. A recall notice says that the materials used to make the syringe let the plunger slip back in the