FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may
FDA Policy/General
Federal Register Notice: FDA is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee notify the agency in writing. It is also requesting nominations for voting industry representatives to serve on the committee.
FDA Policy/General
Attorneys Sheila Boston and Candice Andalia (Kaye Scholer) say that drug and medical device companies should closely follow the evolving FDA regulatory landscape affecting company use of social media. Writing in an online blog post, they review the agency’s regulatory actions taken through Warning Letters, untitled letters, and draft
FDA Policy/General
Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 3/15-16, from 8 a.m. to 6 p.m. at Holiday Inn Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. On 3/15, the committee will discuss an Abbott Vascular PMA
FDA Policy/General
Federal Register Notice: FDA’s Arthritis Advisory Committee will meet 2/9, from 7:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss a Celltrion BLA for
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Alkebulan International Services, LLC Hampton, VA (1/13). Inspected /6-17/15. CGMP deviations, adulterated, unapproved new drugs: The therapeutic claims on the firm’s Web site and on
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications. It provides recommendations on submitting chemistry, manufacturing, and controls and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release
FDA Policy/General
BioLineRx Ltd. will collaborate with Merck to support a Phase 2 study of its BL-8040 in combination with Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic pancreatic cancer. According to the companies, the multi-center study is designed to evaluate the safety and efficacy
FDA Policy/General
BIOLOGICS Guidance on Reducing Creutzfeldt-Jakob Disease Federal Register Notice: FDA is making available a guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry. It provides blood collecting establishments and
FDA Policy/General
DEVICES FDA has cleared a Conavi Medical 510(k) for the Foresight ICE System for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels. The company describes it as the first catheter-based ultrasound system
FDA Policy/General
Federal Register Notice: CDER is sponsoring a public workshop 3/31 entitled “Navigating CDER: What You Should Know for Effective Engagement.” It aims to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. The workshop will be held from 8:30 a.
FDA Policy/General
Federal Register Notice: FDA will hold a public conference 3/23-24 entitled “How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?” This conference will be co-sponsored with the Critical Path Institute and will discuss, debate, and share views among
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information to accompany humanitarian device exemption (HDE) applications and the collection of information on the annual distribution number. Comments should be submitted by 3/15. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Vaccines and Related Biological Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/31/17. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry. It provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations
FDA Policy/General
CBER associate director for medicine Barbara Buch says that the agency has taken “important steps to support the inclusion of diverse populations in clinical trials.” Writing in an FDA Voice blog post, Buch says the agency is implementing Congress’ directive in the FDA Safety and Innovation Act to look more
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 3/2: “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” Its purpose is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s) to be discussed will focus on better
FDA Policy/General
Federal Register Notice: FDA is establishing a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on its pilot “Clinical Outcome Assessment Compendium” (COA). Comments received on the pilot during its pilot phase will help FDA determine its utility, and may
FDA Policy/General
A PwC Health Research Institute analysis projects that the healthcare spending growth rate for 2016 will be 6.5%, down from the 6.8% in 2015. The report identifies three factors that “deflate” the medical cost trend in 2016: the looming Affordable Care Act “Cadillac” tax accelerates cost shifts, virtual
FDA Policy/General
Several Wilson Sonsini attorneys say they expect FDA to begin regulating high-risk laboratory-developed tests (LDTs) early this year. Writing in an online blog post, they say this move will be contentious and that they expect court challenges to the agency’s regulation. “FDA’s regulation of LDTs has
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. Comments should be submitted by 3/14. To view this notice, click here.
FDA Policy/General
The law firm Ballard Spahr has hired Neil P. DiSpirito, an attorney with more than 20 years of experience advising pharmaceutical, medical device, and life sciences clients on compliance with U.S. pharmaceutical, biologic, and medical device regulation. Previously, he was an attorney at Olsson Frank Weeda. DeSpirito also teaches