FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.” The document is intended to aid sponsors developing drugs and biologics for the adjuvant treatment of muscle-invasive bladder cancer. It provides recommendations on eligibility criteria, choice of comparator, follow-
FDA Policy/General
Federal Register notice: FDA has announced the approval of a product that redeemed a priority review voucher — AstraZenca’s sBLA for Ultomiris (ravulizumab-cwvz) that was approved 4/27 for treating adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment.” The document provides recommendations on eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpreting trial results. To view
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Pilot Survey to Develop Standardized Reporting Forms for Federally Funded Public Health Projects.” Respondents to the information collection are recipients of agency-funded projects who submit required information to FDA in free text and narrative form in a
FDA Policy/General
Federal Register notice: FDA has announced that AbbVie had redeemed a priority review voucher to gain its 3/16 approval of a supplemental NDA for Rinvoq (upadacitinib) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.” The document describes FDA’s recommendations for developing such products, including characterizing the potential for QT interval prolongation, performing immunogenicity risk assessments, characterizing the impact of hepatic and renal impairment,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Protection of Human Subjects; Informed Consent; and Institutional Review Boards — 21 CFR Parts 50 and 56” (OMB Control Number 0910-0130). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation.” The guidance says that given the resource-intensive nature of the breakthrough therapy program, the agency periodically assesses whether designated products continue to meet the designation criteria. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.” The document describes methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with non-penicillin beta-lactam antibacterial drugs or
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” The document provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Improving Communication of Important Safety Information — 21 CFR Part 200” (OMB Control Number 0910-0754). The collection supports agency regulations that outline the general provisions for “Dear Healthcare Provider” letters that manufacturers and distributors disseminate about important
FDA Policy/General
The House Appropriations Committee 6/23 voted 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agency’s discretionary funding by $341 million (10%) for a total of $3.645 billion. The bill provides a “targeted increase of $64 million for the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “510(k) Third-Party Review Program” (OMB Control Number 0910-0375). The collection supports the program, such as third-party reviewer requests to participate. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Establishment Registration and Device Listing for Manufacturers and Importers of Devices — 21 CFR Part 807, Subparts A Through D” (OMB Control Number 0910-0625). The collection supports agency regulations that require medical device establishment owners and operators
Drugs
The 4th Circuit Court of Appeals has upheld a West Virginia law regulating ads that solicit plaintiffs for lawsuits involving drugs or medical devices. The appeals court reversed a district court decision that struck down the law on First Amendment grounds. Writing in a Washington Legal Foundation Legal Opinion Letter,
FDA Policy/General
Federal Register notice: CBER has announced a voluntary pilot program for sponsors of CBER-regulated 510(k) submissions entitled Electronic Submission Template and Resource (eSTAR) pilot program. It is intended to improve consistency and efficiency in both industry’s preparation and FDA’s review of such submissions. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” The document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A” (OMB Control Number 0910–0458). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0800). The revision addresses outsourcing facility registrations and the need to submit certain reports and updates to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866” OMB Control Number 0910-0584). The document provides recommendations on measures to help provide a reasonable assurance of safety and effectiveness for
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” The document describes a standards recognition program for regenerative medicine therapies at CBER to identify voluntary consensus standards to help with the development and assessment of such products. To view
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988” (OMB Control Number 0910-0607). The revision pertains to the inclusion of provisions associated with certificates of waiver. In 2020, FDA revised the guidance document entitled “Recommendations for