FDA Policy/General
Federal Register notice: FDA is classifying the conditioning tool for eating disorders into medical device Class 2 (special controls). The decision was based on a de novo classification request by AB Mando for its Mandometer, a prescription device that is intended to measure the mass of food eaten during a
FDA Policy/General
Federal Register notice: FDA is classifying the esophageal tissue characterization system into Class 2 (special controls). The decision was based on a de novo classification request by Diversatek Healthcare for its Mucosal Integrity Conductivity Test System, intended for use in obtaining measurements of electrical properties within esophageal tissue. To view
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of five ANDAs from multiple applicants after they notified the agency that the products are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is classifying isocapnic ventilation devices into Class 2 (special controls), following a de novo classification request from Thornhill Research for its ClearMate device. The agency has identified it as a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/6/2023. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. Nominations received on or before 1/31/2022 will be given first consideration for membership on the committee. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. The document provides sponsors with considerations about designing a registry or proposing to use an existing registry to support a regulatory decision about a
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Pharma Mar’s Zepzelca (lurbinectedin), indicated for treating adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. The review period is 4,170 days, which includes 3,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Prescription Drug User Fee Program” (OMB Control Number 0910-0297). The collection is being revised to include the agency’s current commitment goals outlined in the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through
FDA Policy/General
DEVICES FDA has approved an expanded indication for the Concentric Medical Trevo clot retrieval device to allow treatment of certain stroke patients up to 24 hours after symptom onset, expanding the use to a broader group of patients. An agency news release says the device is cleared for use as
FDA Policy/General
FDA Reclassifying HIV Viral Load Tests 11/24/2021 Federal Register notice: FDA is proposing to reclassify human immunodeficiency virus viral load monitoring tests, a postamendments Class 3 device with the product code MZF, into Class 2 (special controls), subject to premarket notification. To view the notice, click here. Info
FDA Policy/General
Astellas Pharma has agreed to acquire Ganymed Pharmaceuticals AG for $1.4 billion. The transaction will give Astellas rights to IMAB362, which recently was shown to significantly extend median survival when added to standard chemotherapy for patients with advanced gastric cancer. Startup Unity Biotechnology has raised $116 million in a
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Immunomedics’ Trodelvy (sacituzumab govitecan-hziy), indicated for treating adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. The review period is 2,856 days, which
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify human immunodeficiency virus viral load monitoring tests, a postamendments Class 3 device with the product code MZF, into Class 2 (special controls), subject to premarket notification. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Investigational New Drug Applications — 21 CFR Part 312” (OMB Control Number 0910-0014). The collection supports Section 505 of the Federal Food, Drug, and Cosmetic Act and the licensing provisions of the Public Health Service Act that
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Maytee Lledo from providing services in any capacity to a person that has an approved or pending drug product application. The agency contends that while LLedo was employed at Sacred Heart Medical Office in Florida during 2013 through 2016, she
FDA Policy/General
Federal Register notice: FDA is classifying the general laparoscopic power morcellation containment system into Class 2 (special controls). FDA is also codifying the classification by adding 21 CFR 878.4825.1, which is identified as a prescription device consisting of an instrument port and tissue containment method that creates a
FDA Policy/General
New financial disclosure documents showing Robert Califf earning millions of dollars last year from industry could throw a wrench in the confirmation process for the Biden Administration’s pick to lead FDA. “Califf has cashed in on the revolving door both going into government and back out again into the
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from Class 1 (general controls) exempt from premarket notification into Class 2 (special controls) and subject to premarket notification. The affected
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, from Class 3 devices (product code MZO) into Class 2 (general controls and special controls), subject to premarket notification. FDA is also renaming and
FDA Policy/General
Federal Register notice: FDA is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, from Class 3 devices (product codes MZP and OBF) into Class 2 (general controls and special