FDA Policy/General
Federal Register notice: FDA has announced a 7/14 meeting of its Medical Devices Advisory Committee’s Gastroenterology and Urology Devices Panel. The committee is scheduled to discuss, make recommendations, and vote on information on a TransMedics PMA for the Organ Care Liver System, indicated for the resuscitation, preservation, and
FDA Policy/General
Federal Register notice correction: FDA is correcting a 2/12/2018 Federal Register notice to revise the regulatory review period for Merck’s Bravecto (fluralaner), indicated for flea and tick prevention in dogs and cats. The notice is corrected as follows: FDA has determined that the applicable regulatory review period
FDA Policy/General
Former FDA commissioner Stephen Hahn has joined Flagship Pioneering as chief medical officer of its preemptive medicine and health security initiative. Hahn resigned from FDA in January as the new administration took power. Prior to FDA, he was the Chief Medical Executive at MD Anderson Cancer Center. Flagship Pioneering is
FDA Policy/General
The Medicines Company says the Phase 3 clinical trial, TANGO 1, evaluating its antibiotic Carbavance (meropenem-vaborbactam) for treating complicated urinary tract infections, met FDA pre-specified endpoints by showing an overall success rate of 98.4%. The trial randomized 550 adults, it says, to receive either Carbavance via a
FDA Policy/General
Guide on Animal Antimicrobial Drugs 6/11/2021 Federal Register notice: FDA has made available a final guidance for industry (GFI) #263 entitled Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available as
FDA Policy/General
Federal Register notice: FDA has made available a final guidance for industry (GFI) #263 entitled Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available as Over-the-Counter. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug.” The new research is intended to examine physicians’ perceptions and behavioral intentions about an unapproved new use of an
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices — 21 CFR Part 607” (OMB Control Number 0910-0052). The collection supports agency regulations that set forth procedures and requirements pertaining
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance for Industry and FDA Staff — Class 2 Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” (OMB Control Number 0910-0594). The collection supports agency regulations that permit FDA
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is soliciting comment on a proposal to study accelerated approval disclosures on direct-to-consumer (DTC) prescription drug Web sites. A Federal Register announcement of the study comes just days after the controversial 6/7 FDA accelerated approval of Biogen’s Aduhelm
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials. The document provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.
FDA Policy/General
Acting FDA commissioner Janet Woodcock outlined agency budget priorities during a 6/10 Senate Appropriations subcommittee hearing, which included data modernization, supply chain improvements, and the inspection backlog. She told subcommittee members that the agency is requesting a $76 million increase to support data modernization efforts. “As witnessed firsthand during
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “New Animal Drugs for Investigational Use — 21 CFR Part 511 (OMB Control Number 0910–0117).” The collection supports FDA regulations that set forth the conditions for investigational use of new animal drugs and require reporting and recordkeeping.
FDA Policy/General
Federal Register notice: FDA is correcting a document that appeared in the 3/11/2020 Federal Register that announced the agency will begin supporting the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients — 21 CFR Parts 210 and 211 and 21 U.S.C 351(a)(2)(B)” (OMB Control Number 0910-0139). The collection supports
FDA Policy/General
Federal Register notice: FDA has renewed its Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/18/2023.To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published a list of information collections recently approved by OMB. They are: * FDA Recall Regulations (0910-0249) * Premarket Notification for a New Dietary Ingredient (0910-0330) * Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring (0910-0409) * Formal Dispute Resolution; Scientific and Technical Issues
FDA Policy/General
In its response to a National Institute of Standards and Technology (NIST) workshop and call for position papers, FDA says NIST and the National Telecommunications and Information Administration should “continue with and enhance their present approaches to the development of standards and guidelines for operational technology security by leveraging experts
FDA Policy/General
Federal Register notice: FDA has determined that Hospira’s Quelicin Preservative Free (succinylcholine chloride) injection, 20mg/mL, 50mg/mL and 100mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements
FDA Policy/General
Federal Register notice: FDA has determined that Boehringer Ingelheim Pharmaceuticals’ Atrovent (ipratropium bromide) metered spray 0.021 mcg and 0.042 mcg were not withdrawn from sale due to safety or effectiveness reasons. The determination means that the agency will continue to approve ANDAs that refer to the products as
FDA Policy/General
Some Software Functions Exempted from Device Definition 6/4/2021 Federal Register final rule: FDA is amending medical device classification regulations to exclude certain software functions from the definition of a device as mandated by the 21st Century Cures Act’s medical software provisions. The Cures Act amended the definition
FDA Policy/General
Arena Pharmaceuticals GmbH and Roivant Sciences have entered into a development, marketing and supply agreement for nelotanserin, Arena’s inverse agonist of the 5-HT2A receptor. The agreement will give exclusive worldwide rights to develop and commercialize nelotanserin to Roivant. Roivant says it will begin additional Phase 2 clinical trials