FDA Policy/General
Federal Register notice: CDER is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG–DART) and version 1.6 of the CDISC Study Data Tabulation Model (SDTM)
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications” (OMB Control Number 0910-0810). The collection supports educational and public information programs relating to tobacco use. FDA regulations give it authority to conduct research
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Study of Multiple Indications in Direct-to-Consumer Television Advertisements.” The study will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television advertisement. It will also explore whether similarity of
FDA Policy/General
FDA acting commissioner Janet Woodcock seems relieved that FDA is getting back to normal and putting the memory of political pressures from the Trump Administration behind it. Asked during an interview on NPR’s All Things Considered about what has changed now that she is temporarily in charge of the
FDA Policy/General
Federal Register notice: FDA has determined that Eisai’s Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sale for reasons of safety or effectiveness. The determination will prevent any ANDA from being approved that references either product. The drugs are indicated as an adjunct to a reduced-calorie
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in the selection of a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee. For those interested, a letter stating that interest should be sent to FDA by 4/5. To view the notice,
FDA Policy/General
Federal Register notice: FDA is announcing that a collection of information entitled “Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” has been approved by OMB. This is an extension of research that began in 2019. FDA says it has learned about barriers and opportunities encountered
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning to study multiple indications in direct-to-consumer (DTC) TV ads. A Federal Register notice says the study “will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television advertisement. The study also
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debarring former Insys vice president Michael Gurry from providing services in any capacity to a person that has an approved or pending drug product application due to his related conviction of a felony. From early 2012 and continuing through 2015,
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Lawrence B. Ryan from providing services in any capacity to a person that has an approved or pending drug product application due to his related conviction of a felony. From 2007 to 2010, Ryan, a physician, authorized drug orders for
FDA Policy/General
Federal Register notice: FDA has announced a publication containing modifications to the list of standards FDA recognizes for use in premarket reviews — Modifications to the List of Recognized Standards, Recognition List Number: 054. The document is intended to assist manufacturers who elect to declare conformity with consensus standards to meet
FDA Policy/General
Federal Register notice: CDER is proposing to refuse to approve a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. The notice summarizes the grounds for the Center’s proposal and offers Lexicon an opportunity to request a hearing. Sanofi-aventis, Lexicon’
FDA Policy/General
Federal Register notice: FDA has announced a 4/6 Medical Devices Advisory Committee’s Circulatory System Devices Panel meeting. Panel members are scheduled to review a TransMedics PMA for its Organ Care System (OCS) Heart, a portable extracorporeal heart perfusion and monitoring system for the resuscitation, preservation, and assessment of
FDA Policy/General
As a follow-up to its 9/2019 Technology Modernization Action Plan, that laid out a foundation for modernizing the agency’s technical structure and signaled the development of its ongoing strategy concerning data management and data itself, the agency has now released a Data Modernization Action Plan. An online
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients (APIs) — 21 CFR Parts 210 and 211 and 21 U.S.C 351(a)(2)(B)” (OMB Control Number 0910-0139). The collection
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.” Under the collection, FDA is seeking to conduct qualitative
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: HealthQuilt, Houston, TX (2/16) FDA inspected the firm 8/4-8/13/2020 under its bioresearch monitoring program inspection and cited
Drugs
Bristol-Myers Squibb and three U.S.-based Sanofi subsidiaries have been ordered to pay $834 million to the state of Hawaii over marketing and promotion violations involving Plavix, a blood thinner used to reduce the risk of serious cardiovascular events such as heart attacks, strokes and blood clots. Hawaii
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications for lack of compliance with regulation-reporting requirements. They are: * Walco International’s Cuprate (cupric glycinate) * Oxis International’s Palosein (orgotein) * ConAgra Pet Products’ Sergeants Sure Shot (n-
FDA Policy/General
It's five weeks into the Biden presidency and the administration has not yet settled on a pick for FDA commissioner, which apparently does not bode well for the two frontrunners — acting commissioner Janet Woodcock and former FDA principal deputy commissioner Joshua Sharfstein. The commissioner nomination would seem important,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Humanitarian Use Devices (HUD) — 21 CFR Part 814” (OMB Control Number 0910-0332). The collection is intended to assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical