FDA Policy/General
Federal Register notice: FDA has determined that Clinigen’s Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to safety or effectiveness reasons. The determination means the agency can continue to approve ANDAs that reference the product, which is indicated for treating extravasation resulting from intravenous anthracycline chemotherapy and for
FDA Policy/General
Federal Register notice: FDA has announced that it is withdrawing approval of a Secura Bio indication for Copiktra (duvelisib) for treating relapsed or refractory follicular lymphoma. The indication gained accelerated approval 9/2018 and was required to conduct a postmarketing trial to verify the therapy’s clinical benefit. Because the
FDA Policy/General
While removing FDA’s responsibilities for food safety has been kicked around on Capitol Hill for years, a new Politico investigation into CFSAN’s handling of food safety oversight and regulatory activities may draw renewed interest in restructuring the agency to mainly oversee medical products. The investigation examined a number
FDA Policy/General
2 Device Guides on Performance Criteria 04/08/2022 Federal Register notice: FDA has made available two guidance documents for the Safety and Performance Based Pathway. The first is entitled “Surgical Sutures — Performance Criteria for Safety and Performance Based Pathway” and the other is “Orthopedic Fracture Fixation Plates — Performance Criteria
FDA Policy/General
DEVICES St. Jude Medical has gained PMA approval for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s
FDA Policy/General
Varian has acquired privately-held Montreal-based Evinance Innovation, Inc., a clinical decision support software company. The acquisition is expected to expand the capabilities of Varian’s 360 Oncology care management platform by integrating clinical workflow, decision support, and adherence tracking based on leading cancer care guidelines. Merck has agreed
FDA Policy/General
Federal Register notice: FDA has made available two guidance documents for the Safety and Performance Based Pathway. The first is entitled “Surgical Sutures — Performance Criteria for Safety and Performance Based Pathway” and the other is “Orthopedic Fracture Fixation Plates — Performance Criteria for Safety and Performance Based Pathway.” To view the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of drug/biologic clinical studies. It also provides an overview of the types of clinical
FDA Policy/General
Federal Register notice: FDA has announced a 5/11-12 Pediatric Oncology Subcommittee meeting. On 5/11, panel members will discuss the development of a conceptual framework that will guide FDA decisions on sponsor plans and requests for waivers of early pediatric investigations of molecularly targeted cancer drugs/biologics when
Drugs
Bausch Health Companies has received only the second untitled letter from CDER’s Office of Prescription Drug Promotion (OPDP) this year, citing the firm over its promotional communications, a direct-to-consumer video, and an efficacy Web page on its healthcare professional Web site for Duobrii (halobetasol propionate and tazarotene)
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment” that provides general recommendations on the clinical development of such products. It includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Medical Devices; Humanitarian Use Devices — 21 CFR Part 814” (OMB Control Number 0910-0332). The revision addresses a Food Drug & Cosmetic Act provision mandating that the HHS secretary determine the annual distribution number (ADN) for devices
FDA Policy/General
FDA commissioner Robert Califf has laid out a six-part action plan to better leverage health technology, data, and capabilities to improve healthcare outcomes and equity. GovCIO Media reports Califf said during the 4/4 Health Datapalooza that there is a need for private and public entities to work together
FDA Policy/General
Federal Register notice: FDA is announcing a 4/19 virtual public meeting entitled “Medical Device User Fee Amendments” to discuss proposed recommendations for the Medical Device User Fee Amendments reauthorization for fiscal years 2023 through 2027. The meeting is intended to give the public an opportunity to present its views
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Current Good Manufacturing Practices for Positron Emission Tomography Drugs — 21 CFR Part 212” (OMB Control Number 0910-0667). To view the notice, click here.
FDA Policy/General
Comments Extended on Carbadox Carcinogenic Concern 03/30/2022 Federal Register notice: FDA is extending the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. Comments now can be submitted
FDA Policy/General
BIOLOGICS FDA has approved a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who
FDA Policy/General
Millenium Health says it has won a contract worth a potential $1.6 million to provide FDA with urine drug tests for a trial that will assess the development of opioid tolerance in patients taking pain medication with an abuse deterrent formula. The company adds that it has recently agreed
FDA Policy/General
FDA is beginning a pilot program to measure the impact of announced versus unannounced GMP inspections for both domestic and foreign inspections. Speaking at the 3/8 46th International GMP Conference at the University of Georgia in Athens, ORA Office of Pharmaceutical Quality Operations director Alonza Cruse said the two-
FDA Policy/General
FDA says it will roll out this year its Enterprise Data Implementation Roadmap to shape the agency’s future by delivering successful cross-agency efforts that optimize shared business processes, enhance operational efficiency and use of data while strengthening the alignment between agency-wide strategic objectives and investments. In an
FDA Policy/General
Federal Register notice: FDA is extending the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. Comments now can be submitted until 6/10. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). FDA’s regulations require that applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered