FDA Policy/General
Federal Register notice: FDA has announced a 6/8 Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are set to review a Refocus Group PMA for the VisAbility Micro Insert, indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ficosota, Shumen, Bulgaria (2/28): FDA inspected the company 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Ficosota failed to have an appropriate laboratory determination
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications made during 10/2019, 11/2019 and 12/2019. FDA is also making available summaries of the basis of approval and of environmental review
FDA Policy/General
DEVICES FDA has approved a Boston Scientific PMA for the Innova Vascular Self-Expanding Stent System, a treatment for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. The device comprises a Nitinol self-expanding bare metal stent with an advanced delivery system, and is
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to its guidance entitled “Combination Products: How to Write a Pre-Request For Designation (RFD).” The document clarifies the type of information the agency’s Office of Combination Products (OCP) recommends that a sponsor include in a
FDA Policy/General
Federal Register notice: FDA has canceled the 5/15 Allergenic Products Advisory Committee meeting to allow more time for the agency to review outstanding issues related to the safety and efficacy of DBV Technologiesֺ’ Peanut (Arachis hypogaea) Allergen Extract. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has modified the list of standards it recognizes for use in medical device premarket reviews (“Modifications to the List of Recognized Standards, Recognition List Number: 053”). The listing is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain device requirements.
FDA Policy/General
FDA has just released the FDA-483 issued following a 10/2-12/18/17 inspection at Innovative Intrathecal Solutions, doing business as Innovative Compounding Pharmacy, a Marietta, CA, producer of human and veterinary drug products. Specific observations on the form were: * procedures designed to prevent microbiological contamination of drug
FDA Policy/General
Federal Register notice: FDA has canceled a 4/14 public meeting entitled “International Cooperation on Cosmetics Regulation (ICCR) — Preparation for ICCR-14 Meeting.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced its process for making available guidance documents related to the coronavirus public health emergency. The process is intended to allow the agency to rapidly disseminate important virus-related recommendations and policies. For example, FDA notes that prior public participation will not be feasible or
FDA Policy/General
Federal Register notice: FDA has announced the process for making available FDA guidance documents related to the coronavirus outbreak. To act quickly, FDA says prior public participation will not be feasible or appropriate before it implements virus-related guidance documents. Notwithstanding the immediate issuance, FDA still will solicit comments, review
FDA Policy/General
Federal Register notice: FDA has postponed the 4/2-3 Blood Products Advisory Committee meeting due to the coronavirus public health emergency. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Linkeweier Daily Chemicals, Hangzhou, China (3/13) FDA inspected the firm 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to conduct
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Submission of Plans for Cigarette Packages and Cigarette Advertisements.” The document is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. To
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to its guidance entitled “Combination Products: How to Write a Pre-Request For Designation (RFD).” The document clarifies the type of information the agency’s Office of Combination Products (OCP) recommends that a sponsor include in a
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.” The document discusses the temporary compounding of such products by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. To view
FDA Policy/General
DRUGS FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. The expanded approval is intended for patients experiencing disease progression on or after
FDA Policy/General
Clinical-stage oncology company ProNAi Therapeutics has obtained an exclusive license from CarnaBiosciences, Kobe, Japan, for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7. According to the companies, ProNAi will pay Carna Biosciences an initial upfront payment of $0.9 million and additional
FDA Policy/General
Federal Register notice: FDA has permanently debarred Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. Kalinoski previously worked at medical drug repackager Med Prep Consulting. He was convicted of a felony for introducing adulterated and misbranded drugs into
FDA Policy/General
Federal Register notice: FDA has permanently debarred Gerald Tighe from providing services related to an approved or pending drug product application. Tighe was the owner of Med Prep Consulting, a medical drug repackager in New Jersey, and conspired with others to introduce adulterated and misbranded drugs into interstate commerce. To
FDA Policy/General
Federal Register notice: FDA has permanently debarred Brenda Elise Edwards from providing services in any capacity to a person that has an approved or pending drug product application due to a felony conviction. Edwards previously was a Cumberland Distribution employee and engaged in wholesale prescription drug distribution. Cumberland purchased millions
FDA Policy/General
FDA Permanently Debars Kalinoski on ‘Filthy’ Drugs Federal Register notice: FDA permanently debars Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. 03/20/2020 Tighe Permanently Debarred by FDA Federal Register notice: FDA permanently debars Gerald Tighe from