FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy Regarding N-acetyl-L-cysteine.” The document explains the agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L- cysteine (NAC) and are labeled as dietary
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Genentech’s Rozlytrek tablets (entrectinib), indicated for treating certain adult patients with metastatic non-small cell lung cancer, among other indications. The review period is 1,968 days, of which 1,727 days occurred during
FDA Policy/General
Federal Register notice: FDA has permanently debarred Duniel Tejeda from providing services in any capacity to a person that has an approved or pending drug product application. The action is based on Tejeda being convicted of a felony related to his role as a project manager and study coordinator at
FDA Policy/General
The Senate Appropriations Committee has released the fiscal year 2023 proposed budget bill for FDA that increases the agency’s spending by $229 million (7%), but it is $112 million short of what the House proposed in June ($341 million increase). The Senate proposal sets total discretionary funding for FDA
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of seven ANDAs from multiple applicants after they notified the agency that the drugs are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0605). The collection supports required reporting associated with regulations specifying the criteria and procedures for minor uses
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Acceleron Pharma’s Reblozyl (luspatercept-aamt), indicated for treating anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. The regulatory review period is 3,041 days, of which 2,822
FDA Policy/General
The Federal Trade Commission (FTC) has published in the 7/26 Federal Register long-anticipated draft proposed revisions to its “Guides Concerning the Use of Endorsements and Testimonials in Advertising.” Comments can be submitted by 9/26. An online post by Kleinfeld, Kaplan & Becker attorney Samantha Hong expects the
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 5/20 Federal Register announcing the approval withdrawals for 21 ANDAs involving multiple applicants. Bionpharma, Sunny Pharmtech, and Unicorn Pharmaceuticals subsequently notified the agency that the referenced ANDAs should not be withdrawn and FDA is correcting the notice
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings.” The document discusses the inclusion of patients who have not previously received available therapy (commonly referred to as existing treatment options) for their cancer in the non-curative
FDA Policy/General
Federal Register notice FDA is announcing the fiscal year 2023 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. The small business establishment fee is $5,941, non-small business establishment fee is $18,661, and the reinspection
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers — Patient Labeling Recommendations.” The document recommends content and formatting for patient labeling information for LASIK devices. FDA is issuing this guidance to help ensure that physicians can share and patients can understand
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for fiscal year 2023 for animal drug user fees. Under the fee schedule, an animal drug application is $659,364 and a supplemental animal drug application is $329,682. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the company requested the withdrawal due to safety reasons. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Pharmaceutical Voluntary Consensus Standard Recognition.” The collection supports CDER’s implementation of its “Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” It also supports a guidance that outlines procedures to submit requests for
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Alkermes’ Vumerity (diroximel fumarate), indicated for treating certain relapsing forms of multiple sclerosis. The review period is 1,944 days, of which 1,623 days occurred during the testing phase and 321 days during the
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorization (EUA) issued to Gilead Sciences for Veklury (remdesivir) for treating Covid-19 in adults and pediatric patients. The revocation follows FDA approval of a supplemental NDA for Veklury, which expanded the approved indication to cover the EUA-intended population. To
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Orange Book — Questions and Answers.” The document is intended to assist interested parties in using the publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.” The document is intended to assist applicants in responding to complete response letters (CRLs) on ANDAs. It provides information and recommendations about certain actions ANDA applicants
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Conducting Remote Regulatory Assessments — Questions and Answers.” The document describes the agency’s current thinking regarding its use of remote regulatory assessments (RRAs) to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. It
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Kenneth Zipperer for five years from importing or offering for import any drug into the U.S. FDA bases the order on a finding that Zipperer was convicted of one felony count for mail fraud related to the importation of a
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its regulations on the format of the National Drug Code (NDC), an FDA standard for uniquely identifying drug products marketed in the U.S. Specifically, all NDCs will be required to be 12 digits in length with three distinct segments and