FDA Policy/General
Federal Register notice: FDA has announced a 4/8 Pediatric Advisory Committee meeting to discuss drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies (“classic hypogonadism”). The following topics will be considered for
FDA Policy/General
Federal Register notice: FDA is seeking comments on its announced intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The agency has determined that these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other Class 2
FDA Policy/General
Federal Register notice: FDA has classified software applications for contraception into Class 2 (special controls). The action is based on a 2017 Natural Cycles Nordic AB de novo classification request for the company’s Natural Cycles. Such products are identified as a device that provides user-specific fertility information for
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” (OMB Control Number 0910-0582). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866” (OMB Control Number 0910-0584). To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Actavis Laboratories Davie, FL (2/1): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written
FDA Policy/General
One month shy of his second full year in the job, FDA commissioner Scott Gottlieb has resigned to spend more time with his family. Gottlieb commutes from his home in Connecticut, where his wife and three young children reside. He plans to stay on at the agency through the end
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document addresses the agency’s policies for developing a list of bulk drug substances that can be
FDA Policy/General
Federal Register notice: FDA has identified two bulk drug substances that it has considered and is not including on its drug compounding bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need. The affected drugs are nicardipine hydrochloride and vasopressin. Additional bulk drug substances nominated by the
Drugs
Former Insys Therapeutics sales vice president Alec Burlakoff testified in Boston federal court last week on how he followed orders to recruit physician and pay illegal kickbacks to increase the sales of addictive Subsys, a fentanyl-based pain drug. It is the first federal trial involving executives of an opioid
Drugs
CDER Office of Prescription Drug Promotion (OPDP) has cited Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effective on a Web page touting prostate cancer imaging. “Your Web page describes 11C-Acetate as a useful PET scan agent for detecting recurrent prostate cancer,” a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). To view the notice, click here.
FDA Policy/General
Comments Sought on Cannabis Scheduling Recommendations Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions on certain cannabis drug substances. 03/01/2019 Comments Sought on Fentanyl Scheduling Recommendations Federal Register notice: FDA is seeking comments on World Health Organization drug
FDA Policy/General
DEVICES FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic
FDA Policy/General
Federal Register notice: FDA is seeking comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The international drug scheduling recommendations apply to: Dronabinol (delta-9-tetrahydrocannabinol) and its stereoisomers; cannabis, cannabis resin, extracts and tinctures; cannabidiol preparations; and pharmaceutical
FDA Policy/General
Federal Register notice: FDA is seeking comments on World Health Organization drug scheduling recommendations on certain narcotic drugs. The international drug scheduling recommendations apply to: Cyclopropyl fentanyl; methoxyacetyl fentanyl; ortho-fluorofentanyl; para-fluorobutyrfentanyl; n-ethylnorpentylone; and four additional substances. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a public meeting and an opportunity for public comment on “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.” The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to assess commonalities that
FDA Policy/General
Federal Register notice: FDA is amending its regulations to reflect a change of address for CDER’s Office of Generic Drugs Document Room from Rockville, MD, to Beltsville, MD. The new address is: Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Formal Dispute Resolution; Appeals Above the Division Level” (OMB Control Number 0910-0430). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Quality Considerations for Continuous Manufacturing.” The document describes several key quality considerations and provides recommendations for how applicants should address these considerations in various drug submissions for small molecule, solid oral drug products that are produced via a continuous
FDA Policy/General
Timothy Schell has returned to FDA to lead CVM’s the Office of Surveillance and Compliance, effective 2/17. After 14 years at CVM, Schell left the agency in 2014 to join Elanco Animal Health to lead its regulatory affairs strategies in several different areas. He earned a Master of
FDA Policy/General
Federal Register notice: FDA has announced a 3/19-20 meeting of the National Center for Toxicological Research’s (NCTR) Science Advisory Board. On 3/19, panel members are scheduled to hear an NCTR update on scientific initiatives and accomplishments during the past year. On 3/20, representatives from CBER,