Biologics
FDA is permitting Johnson & Johnson (Janssen) to use two batches, but not others, of its Covid-19 vaccine substance made at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations
Drugs
A third advisory committee member — Harvard medical school professor Aaron Kesselheim — has resigned in the wake of FDA’s 6/7 decision to grant accelerated approval for Biogen’s Alzheimer’s therapy. Earlier this week, Mayo Clinic (Rochester, MN) professor David Knopman and Washington University School of Medicine professor Joel
Devices
FDA has cleared a Nuvo Group 510(k) for its InVu remote pregnancy monitoring platform that adds a new module enabling remote monitoring of uterine activity (UA). The company says the device uses only external sensors, allowing it to be used without any invasive component or the need for an
Drugs
An Eli Lilly investigation into whether a company executive altered manufacturing documents required by FDA found no wrongdoing, according to a Reuters report. Law firm Covington & Burling spearheaded the probe of an internal Lilly complaint that alleged a Branchburg, New Jersey factory executive changed technical documents required by regulators
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
Devices
FDA has approved a change to the age indication for Avita Medical’s Recell system in combination with meshed autografting for treating all sizes of acute full-thickness thermal burn wounds in both pediatric and adult patients. The expanded indication removes the prior limitation of use in patients under age
Devices
FDA says the public should stop using the Innova SARS-CoV-2 antigen rapid qualitative test for diagnostic use due to the agency’s “significant concerns that the performance of the test has not been adequately established, presenting a risk to health.” An agency notice says that labeling distributed with
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.
Biologics
With some doses of the Johnson & Johnson one-jab Covid-19 vaccine nearing their expiration date, as vaccination slows in the U.S., FDA has increased the approved refrigerated storage time from 3 months to 4.5 months. In a statement, the company acknowledged the agency’s action and
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
Drugs
FDA has just released the FDA-483s issued following 2019 inspections of two trial investigators at the Hennepin County Medical Center Department of Emergency Medicine in Minneapolis, MN. A 4/10-4/26/19 investigation of Jon Cole, clinical investigator, found these observations: * failing to submit an IND to FDA
Drugs
[Report by David McFarland and Jim Dickinson] In the wake of FDA’s controversial decision to approve Biogen’s Alzheimer’s drug, two members of the advisory committee that reviewed data and voted against approving the therapy have resigned in protest. Mayo Clinic (Rochester, MN) professor David Knopman and Washington
Drugs
FDA has released the FDA-483 issued following a 3/1-1/11 inspection at BSO, a Lakewood, CO, outsourcing facility. The form’s four inspection observations were: * written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up; * procedures for the cleaning and maintenance
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.
Drugs
Acer Therapeutics says it is planning a pivotal clinical trial of its Edsivo (celiprolol) in patients with COL3A1+ vascular Ehlers-Danlos syndrome (vEDS). The company says the agency agreed with its submission of a proposed protocol under a special protocol assessment with a possible breakthrough designation. Minutes from a recent
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
Devices
FDA has approved Medtronic’s Vanta recharge-free implantable neurostimulator that is said to have a device life that can be optimized up to 11 years. The company says that at comparable settings, the Vanta device offers nearly twice the device life of competitive primary cell devices. Medtronic says the
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.
Drugs
FDA has published a draft guidance, Core Patient-Reported Outcomes in Cancer Clinical Trials, with recommendations to sponsors for the collection of a core set of patient-related clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. The document says some of the recommendations
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