FDA Policy/General
The CDER Office of Prescription Drug Promotion is planning to research how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers influence perceptions of a drug. A Federal Register notice says a related question is whether including a disclosure
FDA Policy/General
Federal Register notice: FDA has determined that Novartis Pharmaceuticals’ Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were not withdrawn for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Mekinist is a kinase inhibitor
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health (CDRH).” The collection describes such allegations as claims that a medical device manufacturer or individuals marketing medical devices or electronic products regulated by
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR Part 315.” The collection supports agency regulations in Part 315 where manufacturers of diagnostic radiopharmaceuticals are required to submit information (NDA/BLA) that demonstrates the safety
FDA Policy/General
Hyman, Phelps & McNamara has hired former CDER Office of Immunology and Inflammation director Julie Beitz as a principal drug regulatory expert. Beitz, an oncologist/hematologist, retired 7/29 from the agency after nearly 30 years of service. In her new role, Beitz joins attorneys and other regulatory experts to
FDA Policy/General
Federal Register notice: FDA has determined that the sterile dry powder excipient-free formulation of Baxter Pharmaceuticals’ Cytoxan (cyclophosphamide) for injection, and the sterile dry powder with sodium chloride formulation of Cytoxan (cyclophosphamide) for injection, were not withdrawn for safety or effectiveness reasons. The determination means that FDA can continue
FDA Policy/General
Federal Register notice: FDA is publishing a list of 18 information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. They are: * Premarket Notification Submission 510(k), Subpart E * Good Manufacturing Practice Regulations for Type A Medicated Articles * Tradeoff Analysis
FDA Policy/General
Federal Register notice: FDA is withdrawing 11 ANDAs from Dr. Reddy’s Laboratories after the company requested the actions because the products are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of two Monkeypox-related Emergency Use Authorizations after the authorization holders requested they be revoked because the products are no longer being offered for sale. The affected products are Life Technologies’ TaqPath Monkeypox/Orthopox Virus DNA Kit, and Becton, Dickinson’s Viasure
FDA Policy/General
Federal Register notice: FDA is correcting a 9/19 notice entitled “Food and Drug Administration Information Technology Strategy; Request for Comments.” The document was published with an incorrect set of fiscal year information and this notice corrects this. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the proposed classification of blood irradiator devices for preventing metastasis, which are currently unclassified pre-amendments devices, to Class 3 (general
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of 11 Covid-related Emergency Use Authorizations after the authorization holders requested they be revoked because the products are no longer being offered for sale. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the availability of a draft guidance entitled “Stimulant Use Disorders: Developing Drugs for Treatment.” The document addresses FDA’s current recommendations regarding the overall development program and clinical trial designs for developing drugs to support indications for treating cocaine use disorder, methamphetamine use disorder,
FDA Policy/General
Federal Register notice: FDA is providing notice that the courier address used for user fee payments has changed effective 10/6. The building’s street address has changed from 1005 Convention Plaza, St. Louis, MO 63101, to 3180 Rider Trail South, Earth City, MO 63045. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is announcing that it revoked the Emergency Use Authorization issued to Becton, Dickinson for the BD Vacutainer Plus Citrate Plasma Tubes. The revocation was requested by BD because the product is no longer being sold. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Pharmaceuticals’ Ultram (tramadol hydrochloride) tablets, 50 mg, was not withdrawn from sale for safety or effectiveness reasons. The determination means the agency can continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Ultram
FDA Policy/General
Federal Register notice: FDA is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including for when the IVD is a laboratory-developed test (LDT). The agency is also proposing a policy under which it
FDA Policy/General
Federal Register notice: FDA is announcing an 11/16 Oncologic Drugs Advisory Committee meeting to hear an update on the agency’s accelerated approval program for oncology products. Panel members will also discuss two accelerated approval NDAs that have not met their agreed-upon milestones for completing confirmatory trials. The
FDA Policy/General
FDA has issued Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating moderate-to-severe glabellar lines (frown lines) associated with corrugator or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — ‘Dose Banding.’” The document is intended to assist applicants in incorporating dose banding information, based on dosing information
FDA Policy/General
Federal Register notice: FDA is announcing the opportunity for a limited number of development programs to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program, which is intended to advance development of drugs/biologics that are intended to treat rare diseases. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control (PCLC) Technology.” PCLC devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. FDA says they may