FDA Policy/General
An Annenberg Public Policy Center survey shows FDA, CDC, and Anthony Fauci continue to be trusted by the vast majority of Americans. An Annenberg Center release says the survey also shows growing public confidence in Covid-19 vaccine safety and effectiveness. The survey found 77% of respondents are confident that
Devices
Regulatory flexibility and developer engagement are two lasting lessons that CDRH has to learn from the Covid-19 emergency, according to director Jeff Shuren. Speaking at an Alliance for a Stronger FDA update 7/22, Shuren said that "these two together were really the drivers of our ability to
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by The Regen Centers, Rancho Mirage, CA, determined that the firm markets cellular products derived from human umbilical cord blood, umbilical cord tissue, amniotic membrane, or adipose tissue, which the company refers to as
Drugs
Bipartisan leadership of the House Energy and Commerce Committee is asking FDA acting commissioner Janet Woodcock for information on agency efforts to mitigate the backlog of drug manufacturing facility inspections and human drug applications to ensure patient access to safe and effective medicines. A 7/22 letter says committee members
Drugs
FDA has published a guidance, Field Alert Report Submission Questions and Answers, giving the agency’s current thinking on the requirements for submitting field alert reports (FAR) by NDA and ANDA applicants. The document outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. It also
Drugs
FDA has placed a clinical hold on a Magenta Therapeutics Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The company says the agency is “requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/
Devices
Vero Biotech is recalling its Genosyl DS; Nitric Oxide Delivery System due to a software issue that leads to errors in gas delivery. “Typically, this issue caused delivery of lower-than-expected dosage of nitric oxide during the transition between primary and backup console,” a recall notice says. “If this
Devices
FDA acting commissioner Janet Woodcock says part of the agency’s FY 2022 budget request is for $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program in CDRH. Writing in an FDA Voices online post, Woodcock says the funding “will provide, for the first time, resources
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site and Facebook page maintained by The Dahlia Center, Medina, OH, indicates that the company offers a cellular product derived from umbilical cord to treat Covid-19 or to prevent Covid-19 associated respiratory conditions via
Drugs
The CDER Office of Compliance says a review of the Web site and social media sites maintained by Jordan’s Crossing Herbal Connections, Barnsdall, OK, determined that the company is offering its “Germaphobe’s Delight Spray” to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 7/20
Devices
FDA has granted AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA methylation detection. The test is intended as an alternative to traditional cystoscopy. It is designed to detect bladder cancer through random urine collection and conducting methylation detection of exfoliated
Devices
Mintz attorneys say an FDA draft remanufacturing guidance issued 7/24 may be a step in the right direction to help entities identify when they are performing remanufacturing activities and thus subject to agency regulation, but does not provide a clear process for such determinations. The analysis says a flowchart
Drugs
FDA has granted Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS). The designation was granted based on interim results from the Phase Ib M15-531 study investigating Venclexta plus azacitidine
Devices
FDA has cleared a Zoll Medical 510(k) for its TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator. The dashboard provides clinical decision support for managing patients with traumatic brain injury, and was previously available on Propaq devices sold in international markets. The device is
Drugs
Covis Pharma is asking FDA to take several administrative actions on a Eugia Pharma NDA for a generic version of Makena Autoinjector. A 7/19 petition asks that the agency (1) review the basis for submission of the ANDA; (2) determine that the ANDA should have been filed as a
Biologics
The CBER Office of Compliance and Biologics Quality says A Better Life Stem Cell Center, Las Vegas, NV, is marketing cellular products that appear to be derived from umbilical cord or umbilical cord blood that A Better Life refers to as “stem cell therapy” for numerous diseases or conditions such
Devices
An online Evaluate Vantage post says FDA awarded just 12 first-time PMAs and one HDE during the first six months of this year. The post says that if the agency maintains the same approval rate in the second half of the year, it will see the fewest high-risk
Drugs
FDA says Pfizer has expanded its recall of Chantix (varenicline) to 12 lots to the consumer level due to the presence of N-nitroso-varenicline above the company’s acceptable limit for this impurity. The company initially recalled nine lots of the drug 7/2. An agency update also says
Drugs
To attempt to stave off government drug price regulation, the Business Group on Health’s Pharmaceutical Supply Chain Leadership Forum (PSCLF) is calling on stakeholders to reform the drug supply chain based on principles and recommendations released following a two-year PSCLF study. “In an environment of high and rising
Devices
FDA has cleared a First Light Diagnostics 510(k) for its SensiTox C. difficile toxin test along with its proprietary MultiPath Analyzer. C.difficile causes more life-threatening hospital infections than any other pathogen and is considered by the CDC to be an urgent antibiotic resistance threat, according to the
Drugs
FDA has announced a class-wide labeling change for cholesterol-lowering statin drugs to remove its strongest warning against their use in pregnant patients. “We have conducted a comprehensive review of all available data and are requesting that statin manufacturers make this change to the prescribing information as part of
Drugs
FDA has denied a 2/12/20 petition submitted by an Ohio State University College of Medicine emeritus professor asking the agency to revoke its approval of tolvaptan (Osaka’s Jynarque) for treating autosomal dominant polycystic kidney disease. The petition says FDA approval should be revoked because the drug is