FDA Policy/General
Federal Register notice: FDA has issued an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases the order on a finding that Fleming was convicted of two felonies under federal
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Datascope Corp. Fairfield, NJ (9/11): FDA inspected the firm in June and cited GMP violations for medical devices. For example, the firm failed to maintain the requirements, including
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.” The document provides recommendations on the content and submission procedures for use-related risk analyses, human factors validation study protocols
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides advice on the appropriate use of adaptive designs for clinical trials. It also describes the basic principles for designing, conducting, and reporting the results from an adaptive
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” The document provides advice to sponsors intending to simultaneously evaluate more than one investigational drug or more than one cancer type within the same
FDA Policy/General
Former Able Labs Quality Manager Debarred Federal Register notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. 09/28/
FDA Policy/General
Federal Register notice: FDA has denied a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases its order on a finding
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device (regulated under product code MBU), into Class 2 (special controls) subject to premarket notification (510(k)). FDA is also amending the existing
FDA Policy/General
Federal Register notice: FDA has reopened the comment period related to two draft guidance documents entitled “Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies” and ”Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies Draft Companion Guidance Document.” Comments can be submitted until 12/26. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of seven ANDAs from multiple applicants after they notified the agency in writing that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Insanitary Conditions at Compounding Facilities.” The document is intended to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions. It is also intended to help state regulatory agencies understand some examples of what FDA
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.” The document describes how FDA intends to apply section 503B of the federal Food, Drug, and Cosmetic Act to radiopharmaceuticals compounded by outsourcing facilities, and it describes the conditions where the
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 2019 — $2,457,140. The voucher fee is expected to be paid in addition to any drug user fee required for such an application. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced an 11/2 joint Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss the efficacy, safety, and benefit-risk profile of a Sage Therapeutics NDA for brexanolone 5 mg/mL intravenous injection, indicated for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.” The draft clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. To
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “ANDA Submissions — Content and Format.” The document details the information that should be provided in each section of the common technical document format and identifies supporting guidance documents and recommendations to assist applicants in preparing their ANDA submission. To
FDA Policy/General
Federal Register notice: FDA has announced an opportunity for public comment on an information collection extension entitled “Generic Drug User Fee Cover Sheet.” To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Wilson Medicine Co. Nandore, India (9/11): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For
FDA Policy/General
Federal Register notice: FDA has reopened the comment the comment period provided in a 2/16 notice entitled “Pediatric Medical Device Development; Public Meeting; Request for Comments. ” Comments now can be accepted until 11/26. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has set the fee rate for using a tropical disease priority review voucher at $2,456,140 for fiscal year 2019. The fee is in addition to any drug user fee that is required for such an application. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class 3 device (regulated under product code LZR) into Class 2 (special controls), subject to a premarket notification 510(k) submission. This device is indicated for treating refractory glaucoma; it is intended for
FDA Policy/General
FDA has posted a draft guidance entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.” The document is intended to provide recommendations to industry and review staff to ensure that the review process is managed in a consistent and efficient manner, thereby decreasing the