Drugs
An 11/14-11/21/22 FDA inspection at Centaur Pharmaceuticals Private Ltd. in Mumbai, India, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 6/5 Warning Letter says the specific deviations were: * failure of the quality unit to exercise
Devices
A 1/17-2/10 FDA inspection at Outset Medical in San Jose, CA, found that the company manufactures the Tablo Hemodialysis System and TabloCart with Prefiltration. A 7/5 Warning Letter says Outset does not have approved applications for PMA approval for either of the devices, rendering them both
Drugs
The CDER Office of Translational Sciences (OTS) says it “works collaboratively to help drive advancements in human health through scientific and regulatory innovation.” The OTS 2022 annual report says its tasks have included: * promoting scientific collaboration and innovation in drug regulatory review across CDER; * assuring the validity of clinical trial
Drugs
Bipartisan leaders of the House Energy and Commerce Committee say they are concerned about the effectiveness of FDA drug inspection efforts in India and China. In a 7/18 letter to FDA commissioner Robert Califf, the lawmakers say the agency’s recent decision to address shortages of critical drugs by
Drugs
Akebia Therapeutics says it has completed an “End of Dispute Type A meeting” with FDA that discussed the company’s upcoming NDA resubmission for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. In May, CDER’s Office of New Drugs (OND)
Devices
Medtronic has recalled (Class 1) its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with glassed feedthrough due to a potential faulty short circuit protection feature. A recall notice says the glassed feedthrough devices “may deliver low or no energy output when high voltage therapy is needed due to inappropriate
Drugs
Olympus has recalled (Class 1) about 1,500 OES BronchoFiberscope BF Type devices after receiving complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. The company has issued an “Urgent Medical Device Corrective Action” letter to customers telling them that labeling will be updated to include specificity about
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on scientific considerations for pediatric drug development under the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) “offers valuable direction on various important scientific considerations for pediatric drug development programs, including considerations regarding
Biologics
The Government Accountability Office (GAO) says its study of regenerative medicine led to the development of 11 policy options, several of which involve FDA. GAO says it conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. The report looks at (1) current and emerging regenerative medicine
Drugs
FDA has accepted for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment for unresectable hepatocellular carcinoma (uHCC). The agency has set a user fee review action target date of 5/16/2024. The
Devices
FDA has issued a warning against using ultrasound medical devices manufactured and distributed by RoyalVibe Health, and related companies CellQuicken and Well-Being Reality. The agency says the devices have not been reviewed for safety or effectiveness, and using them “may result in adverse effects, including pain, bruising, burns, scarring,
Drugs
Eli Lilly has announced full results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease (AD). The data were published 7/17 online in the Journal of the American Medical Association. Lilly filed for
Drugs
BridgeBio Pharma says it plans to file an NDA by the end of the year after reporting “positive results” from ATTRibute-CM, a Phase 3 study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM. “ATTR-CM is an increasingly recognized cause of heart failure,” a company release says. The
Drugs
FDA has issued Catalent a four-page Form FDA-483 after inspecting the firm’s Bloomington, IN manufacturing facility 5/4-12. According to the inspection form, Catalent was cited over written production and process control procedures not being followed or established. Additionally, the agency said the facility’s equipment
Devices
Quidel Cardiovascular has recalled (Class 1) the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower-than-expected troponin levels in samples. “A falsely low or false negative troponin level may cause a delayed or missed diagnosis of myocardial infarction — a serious, potentially fatal condition that requires the
Devices
FDA has made minor changes to its final guidance entitled “Qualification of Medical Device Development Tools (MDDTs).” The document describes the agency’s voluntary program for qualifying MDDTs for use in evaluating devices regulated by CDRH. The Center says the following minor procedural updates and clarifications were made to the
FDA Policy/General
Former FDA chief counsel (2001-2004) Dan Troy has joined Berkeley Research Group (BRG) in the firm’s Washington, DC office as a managing director in its Health Analytics practice. At BRG, Troy will “provide senior-level expertise in FDA regulatory matters and bolster the practice’s ability to address
Biologics
FDA has approved an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age. Approval of the monoclonal antibody was based on data
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Sarepta Therapeutics for its recently approved rare pediatric disease product application — Elevidys (delandistrogene moxeparvovec-rokl), indicated for treating ambulatory pediatric patients aged four through five years with Duchenne muscular dystrophy. Earlier this month, the company indicated
FDA Policy/General
Federal Register notice: FDA and the Clinical Trials Transformation Initiative (CTTI) are requesting applications from patient advocates interested in participating on the Patient Engagement Collaborative (PEC). Through the PEC, the patient community and FDA staff are able to discuss topics related to increasing meaningful patient engagement with diverse populations in
Drugs
A 3/6-completed FDA inspection of Fresenius Kabi’s Canton, MA outsourcing facility resulted in a two-item Form FDA-483 that cited the firm over GMP deviations. For example, the facility’s procedures to prevent microbiological contamination of drug products purporting to be sterile are not established, written,
Devices
FDA has cleared a MedRhythms 510(k) for InTandem, a neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits. The device delivers an intervention based on rhythmic auditory stimulation, a “well-researched clinical intervention utilizing the mechanism of auditory-motor entrainment, through which the motor