Devices
A new FDA final rule on the medical device de novo marketing pathway has modified earlier language contained in the proposed rule to now permit manufacturing inspections in limited scenarios. The rule establishes procedures and criteria for submitting a de novo request, which can occur after a device sponsor receives
FDA Policy/General
Federal Register notice: FDA has announced that 23 information collections have been approved by OMB. They are: * Blood Establishment Registration and Product Listing for Manufacturers of Blood and Blood Products and Licensed Devices * Current Good Manufacturing Practice: Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals * Irradiation in
Drugs
Teva Pharmaceuticals has temporarily stopped production at its Irvine, CA manufacturing facility after a recent FDA inspection cited manufacturing concerns and the company recalled 2.5 million vials of drugs that may not be sterile. The drug vials recalled include those for treating cancer, arthritis, schizophrenia and a muscle relaxer
Devices
FDA has released a document entitled “Best Practices for Communicating Cybersecurity Vulnerabilities to Patients.” The document is intended to provides helpful information and elements for industry stakeholders, federal partners, and other interested stakeholders to consider when developing a cybersecurity communication strategy. It was developed based on comments submitted to the
FDA Policy/General
Draft Guide on Investigator Safety Reporting 9/30/2021 Federal Register notice: FDA has released a draft guidance entitled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices. The document is intended to help clinical investigators to identify safety information that is considered an unanticipated problem involving risk to human
FDA Policy/General
China-based 3SBio Inc. has entered into an asset purchase agreement with Canada-based biologics manufacturer Therapure Biopharma Inc. to acquire its contract development and manufacturing business for $290 million. The acquisition is intended to allow 3SBio improve its connections with global biotechnology and pharmaceutical companies in order to form
FDA Policy/General
DEVICES FDA has approved Grifols’ Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The assay is also approved for testing plasma or serum specimens to screen other living (heart-beating)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. The document is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use
Biologics
FDA has announced a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss booster doses for both Moderna and Janssen Covid-19 vaccines. Panel members are also scheduled to discuss available data on the use of a booster of a different vaccine than the one used
Drugs
Merck plans to submit soon an application seeking emergency use authorization (EUA) for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine that new data show significantly reduced the risk of hospitalization or death in Covid-19 patients. Merck and developmental partner Ridgeback Biotherapeutics just announced data from a
Devices
A new medical device user fee program independent assessment by Booz Allen finds that even during the pandemic and an increasing workload, CDRH continued to meet goals agreed upon its user fee commitment letter. The assessment, however, did find concerns with the Center’s new Electronic Submission Template And Resource
Drugs
Bayer has recalled all unexpired Lotrimin AF and Tinactin spray products (lot numbers beginning with TN, CV or NAA) due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products, according to a recall notice. “Benzene is
FDA Policy/General
Federal Register notice: FDA has extended the comment period for the notice entitled Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments that appeared in the 8/9 Federal Register. A 4/16 decision affirmed a district court ruling that FDA is not afforded discretion
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial. The document addresses how sponsors can gather preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations. The document provides FDA’s current thinking on certain criteria that help determine gene therapy sameness for the purposes of orphan-drug designation and orphan-drug exclusivity. To
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices. The document is intended to help clinical investigators to identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Benefit-Risk Assessment for New Drug and Biological Products. The document is intended to provide drug sponsors and other stakeholders with a clearer understanding about how considerations about a drug’s benefits, risks, and risk management options factor into
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Microbiological Quality Considerations in Non-Sterile Drug Manufacturing. The document discusses product development considerations, risk assessments, and certain GMP requirements that are particularly relevant to microbiological control in a manufacturing operation for such products. To view the notice, click
Biologics
FDA has published two guidances relating to gene therapy products. The first, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations, gives the agency’s current thinking on determining the sameness of these products for orphan drug designation and exclusivity. It is intended to assist stakeholders in developing
Devices
FDA has granted 510(k) clearance to Siemens Medical Solutions’ NAEOTOM Alpha computed tomography (CT) imaging device. An agency notice says the device is the “first major technological improvement for CT imaging in nearly a decade.” The device uses the emerging CT technology of photon-counting detectors that can measure
Drugs
CDER drug safety operations (DSO) associate director Terry Toigo is retiring 9/30 and, in the interim, DSO senior staff member Amy Ramanadham has been named acting associate director. Ramanadham joined DSO in 2012 after completing a doctoral degree in pharmacy at the University of Maryland, School of Pharmacy. She
Drugs
The 11th Circuit Court of Appeals has overturned a Florida federal court decision granting summary judgment to FDA and Jacobus Pharmaceutical and dismissing Catalyst Pharmaceuticals’ case involving orphan drug exclusivity for its Firdapse (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS). Catalyst had challenged FDA’s approval of Jacobus’ Ruzurgi