Devices
Senseonics Holdings has submitted a PMA supplement seeking to extend the wearable life of the Eversense Continuous Glucose Monitoring System from 90 to 180 days. The submission was based on data from the PROMISE clinical study. The 181-patient trial had participants have the Eversense sensor inserted subcutaneously at eight
FDA Policy/General
Federal Register notice: FDA has announced the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2021. The fee amount is $1,360,879 and it must be submitted with a priority review voucher for a human drug application, in addition to any Prescription
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorizations issued to Autobio Diagnostics for the Anti-SARS-CoV–2 Rapid Test because of poor device performance. To view the notice, click here.
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Nalpropion Pharmaceuticals a Warning Letter about a sponsored link appearing on Google’s search engine for Contrave (naltrexone hydrochloride and bupropion hydrochloride), citing the company for false or misleading claims about the risks associated with the drug’s efficacy. “These
FDA Policy/General
Federal Register notice: FDA has postponed until further notice a 10/7 meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel, which was scheduled to discuss a TransMedics PMA for its Organ Care System — Heart. The portable ex-vivo organ perfusion and monitoring system is indicated for
Drugs
In a rare product approval reversal, FDA has issued a proposal to withdraw from the market Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market because a required postmarket study failed to verify clinical benefit in reducing the risk of preterm birth in women who previously had a spontaneous (unexplained)
FDA Policy/General
Nephron Pharmaceuticals has been issued what looks to be the first Warning Letter to cite a prescription drug manufacturer for promoting its product for an unapproved use in treating Covid-19. The letter from CDER’s Office of Prescription Drug Promotion (OPDP) cited emails about Nephron’s budesonide inhalation suspension
Drugs
A new CDER investigation of real-world evidence confirms that patients taking levothyroxine benefit equally from generic and brand-name drugs. The study, the agency says, confirms that real-world equivalence, just like clinical trial data, shows that generic drugs are therapeutically equivalent to brand-name drugs. The review by
FDA Policy/General
Accredited Persons Inspection Program Info Collection Federal Register notice: FDA sends to OMB an information collection extension for its device accredited persons inspection program. 07/19/2019 FDA Adopts Geopolitical Naming/Coding Standard Federal Register notice: FDA announces that it will adopt the current version of the Geopolitical Entities, Names,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment. The document addresses comments received after an 8/7/2018 draft guidance was released. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Orphan Drugs; 21 CFR Part 316” (OMB Control Number 0910-0167). The collection is being revised to include Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan
Devices
FDA has classified as Class 1 a recall of Becton Dickinson’s Alaris Pump Module and Pump Module Door Assembly Replacement Kits because the keypad may have one or more keys that become unresponsive or stuck. The infusion pump module delivers fluids, medications, blood and blood products into a patient’
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment. The document provides recommendations to sponsors on eligibility criteria, choice of comparator, follow up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results.
Devices
FDA has updated its information Web page about eligibility for its Voluntary Malfunction Summary Reporting program. The program allows manufacturers to report certain device malfunction Medical Device Reports in summary form on a quarterly basis. The updated information is related to: * How to identify a device product code eligible for
Biologics
FDA has issued Mesoblast a complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease. The agency letter recommended that the company conduct at least one additional randomized, controlled study in adults or children to provide further evidence of the therapy’
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment. The document includes recommendations on eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. To
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery. An FDA news release says this is the first drug regimen approved for mesothelioma in 16 years. The drug
Drugs
After being confirmed to be infected with Covid-19 late 10/1, President Trump 10/2 was given an investigational drug cocktail from Regeneron that is still undergoing clinical trials. Trump presumably was granted access under an expanded (compassionate use) access protocol. Late in the day, the press pool was
FDA Policy/General
FDA has renewed and expanded its licenses of Certara’s biosimulation software with more than 400 user licenses of the company’s Simcyp and Phoenix platforms. A company announcement says 11 FDA divisions and offices use the Certara software for internal research and to independently analyze, verify, and review regulatory
Drugs
FDA has published a guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment, to help sponsors develop drugs to treat opioid use disorder. The document addresses clinical endpoints acceptable for demonstrating the effectiveness of such drugs. It does not address the development of drugs intended only to
Drugs
FDA has published two guidances with recommendations for sponsors on developing drugs and biologics for the adjuvant treatment of renal cell carcinoma and muscle-invasive bladder cancer. Each document has recommendations about eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. The document provides general recommendations about the development, evaluation, and use of physiologically based pharmacokinetic analyses for biopharmaceutics applications used in