FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning research to better understand the landscape of healthcare provider-directed promotion of prescription drugs at medical conferences in general and, more specifically, how elements of pharmaceutical booths in medical conference exhibit halls affect healthcare professionals’ perceptions of the drugs that
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs. The document notes that eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species to include certain major uses in major
FDA Policy/General
Federal Register notice: FDA has announced that it has issued a priority review voucher to Mallinckrodt’s Stratatech unit after approving its material threat medical countermeasure product application — Stratagraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen—dsat). The product is indicated for treating adults with thermal burns containing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports implementation of medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. FDA says the revision was made to
FDA Policy/General
Federal Register notice: FDA is correcting a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants. That notice included two ANDAs that had been previously withdrawn in an earlier notice. This notice corrects the error. To view the notice, click here.
FDA Policy/General
Notice Corrected on 2 ANDA Withdrawals 7/9/2021 Federal Register notice: FDA is correcting a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants. That notice included two ANDAs that had been previously withdrawn in an earlier notice. This notice corrects the error. To view
FDA Policy/General
Federal Register notice: HHS has withdrawn a 1/21 notice entitled “Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.” It is also withdrawing associated requests for proposals issued on its Web site. The department says it is not aware that any proposals were received in response to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm), indicated for preventing migraines in adults. The regulatory review period is 3,216 days, which includes 2,882 days that occurred during the testing phase and 334 days during the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Piqray (alpelisib), indicated in combination with fulvestrant for treating postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Beovu (brolucizumab-dbll), indicated for treating neovascular (wet) age-related macular degeneration. The regulatory review period is 3,064 days, which includes 2,821 days that occurred during the testing phase and 243 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Acacia Pharma’s Barhemsys (amisulpride), indicated in adults for preventing postoperative nausea and vomiting. The regulatory review period for is 2,960 days, which includes 2,085 days that occurred during the testing phase and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The document describes the requirements and recommendations for UDIs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Pulmonx Corp.’s Zephyr Endobronchial Valve Implant, indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. The regulatory
FDA Policy/General
7/2/2021 Topical and Transdermal Adhesion Assessments Guide Federal Register notice: FDA has made available a draft guidance entitled Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. To view the notice, click here. Guide on CNS Cancer Drugs Federal Register notice: FDA has made
FDA Policy/General
FDA acting commissioner Janet Woodcock says the agency’s FY 2022 budget requests an increase of $185 million “to embark on an effort to upgrade and modernize our physical and technological infrastructure, strengthen our talented workforce, and improve our scientific capability and regulatory structure.” Writing in an FDA Voices online
FDA Policy/General
7/2/2021 Topical and Transdermal Adhesion Assessments Guide Federal Register notice: FDA has made available a draft guidance entitled Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. To view the notice, click here. Guide on CNS Cancer Drugs Federal Register notice: FDA has made
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Tuesday, July 6. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Class II Special Controls for Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests.” The collection is intended to support a 2020 proposed order to reclassify certain HIV
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements — 21 CFR Part 203” (OMB Control Number 0910-0435). To view the notice, click here.
FDA Policy/General
The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 6/25 has approved by voice vote FDA’s s fiscal year 2022 budget bill. Under the measure, the agency would receive $3.471 billion in discretionary funding in the bill, an increase of $257
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings. The document provides recommendations on cancer drug trials regarding the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Covid– 19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention. The document primarily focuses on the trial design and conduct as well as statistical considerations for master protocols intended to generate substantial effectiveness evidence and adequate