FDA Policy/General
Federal Register notice: FDA is seeking comments on a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. The devices are battery-powered tables with wheels that are intended for use by patients who are unable to propel themselves independently and who must maintain a prone or
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of an Impax ANDA for ursodiol capsules USP, 300 mg. Impax requested the withdrawal based on FDA’s concerns about the validity of bioequivalence data from an undisclosed contract research organization. Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones
FDA Policy/General
Guide on Special 510(k) Program Federal Register notice: FDA makes available a final guidance entitled “The Special 510(k) Program.” 09/13/2019 FDA Posts 9 OMB-approved Info Collections Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB. 09/13/
FDA Policy/General
Mylan says it will acquire Meda AB in a $7.2 billion cash-and-stock deal. This was the third attempt by Mylan to buy the Swedish company.The offer, recommended by Meda’s board, valued the company at $9.9 billion, including debt. RedHill Biopharma has submitted to FDA
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “The Special 510(k) Program.” The document provides the framework that FDA uses when considering whether a premarket notification 510(k) is appropriate for review as a Special 510(k). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has released a list of information collections that have been approved by OMB. They are: * Disease Awareness and Prescription Drug Promotion on Television * Reporting Associated with New Animal Drug Applications and Veterinary Master * Substances Generally Recognized as Safe: Notification Procedure * Establishing and Maintaining Lists of U.
FDA Policy/General
Federal Register notice: FDA has announced a 10/7 Science Board advisory committee meeting. The panel is scheduled to hear a response from CBER to the recommendations made by the Science Board’s review of its research program. The Science Board will also discuss whether there are any relevant published
FDA Policy/General
Federal Register notice: FDA has announced an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection not responsive to standard therapies. FDA will consider scientific data and other information from the hearing to consider ways to support FMT
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Edwards Lifesciences’ Pericardial Aortic Bioprosthesis, indicated for replacement of native or prosthetic aortic heart valves. The review period is 1,858 days, which includes 1,491 days that occurred during the testing phase and 367
FDA Policy/General
Federal Register notice: FDA has determined that Sanofi Aventis’ Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Calcimar if all other legal and regulatory requirements are met. To view the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Tsunami MedTech’s Aegea Vapor System, indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes in whom childbearing is complete. The review period is 1,
FDA Policy/General
Federal Register notice: FDA is requesting comments on 21 drug substances concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use. The comments will be considered in preparing a response from the U.S. to the World Health Organization to use in
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Enprani Co., Seoul, South Korea (8/15): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, The company failed to have, for
Drugs
The Federal Trade Commission (FTC) says it has sent warning letters to three unnamed companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD), a chemical compound derived from the cannabis plant. The letters tell the companies that it is illegal to advertise that a product can prevent,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Devices; Use of Symbols in Labeling — Glossary To Support the Use of Symbols in Labeling” (OMB Control Number 0910-0740). The collection supports an FDA final rule revising medical device and certain biological product labeling regulations
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 25 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Acceptance Review for De Novo Classification Requests.” The document explains the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic Class III designation (De Novo classification request or De Novo request)
FDA Policy/General
Federal Register notice: FDA has announced its adoption of the most current set of the Unified Code for Units of Measure (UCUM) codes. The UCUM is a terminology standard that contains a system of coding units of measure used in science and medicine. UCUM offers a single coding system for
FDA Policy/General
Senator Richard Durbin (D-IL) has written FDA acting commissioner Ned Sharpless urging him to take immediate and decisive action to curb the e-cigarette and vaping epidemic that threatens young adults and children in the U.S. or resign. In a 9/6 letter, Durbin said that as acting
FDA Policy/General
FDA is just weeks away from announcing a new plan to modernize its technology infrastructure to help it keep pace with the evolving tech landscape in product development and surveillance. Addressing a Reasearch!America conference in Washington, DC 9/6, acting commissioner Ned Sharpless said an improved information technology platform
FDA Policy/General
FDA 9/9 has issued a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products by “engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.” The agency also sent a letter to the company requesting more
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for GlaxoSmithKline Biologicals’ Shingrix (zoster vaccine recombinant, adjuvanted), a vaccine indicated for preventing herpes zoster (shingles) in adults aged 50 years and older. The review period is 3,257 days, which includes 2,892 days that