Biologics
FDA has granted TapImmune a fast track designation for its cancer vaccine TPIV 200 and its use in treating ovarian cancer. The designation covers the use of multiple-epitope folate receptor alpha peptide vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian
Drugs
FDA has granted Conatus Pharmaceuticals a fast track designation for emricasan and its development program for treating liver cirrhosis caused by nonalcoholic steatohepatitis (NASH). “The data from our recently completed Portal Hypertension trial, showing clinically meaningful reductions in hepatic venous pressure gradient (HVPG) in patients with severe portal hypertension after
Biologics
FDA has issued Telesta Therapeutics a complete response letter on its BLA for MCNA (Mycobacterium phlei cell wall-nucleic acid complex), indicated for treating high risk non-muscle invasive bladder cancer patients who have failed front line Bacillus Calmette-Guerin therapy. The agency’s letter indicated that an additional Phase
Devices
FDA has issued two guidances dealing with human factors in medical devices. The first, a draft guidance, List of High Priority Devices for Human Factors Review, is to inform medical device manufacturers which device types should have human factors data included in premarket submissions. The document says that the agency
FDA Policy/General
Federal Register Notice: CBER is inviting biologics facilities to contact the Center for more information on participating in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities to allow CBER staff
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
Drugs
A 2/1 Congressional briefing by the Generic Pharmaceutical Association (GPhA) concluded that generic drug prices are not an important part of the drug cost problem facing the nation. The group reiterated findings from a recent HHS brief on Understanding Recent Trends in Generic Drug Prices, which revealed that about
Devices
FDA has issued a draft guidance, Enforcement Policy of National Health Related Item Code and National Drug Code Numbers Assigned to Devices, describing the agency’s intent not to enforce before 9/24/21 the prohibition against providing National Health Related Item Code or National Drug Code numbers on device
Drugs
FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) 2/3 will discuss whether cognitive impairment in major depressive disorder (MDD) is a suitable target for drug development, and if so, how it should be studied. Briefing materials released in advance of the meeting note that, historically, CDER’s Division of Psychiatry
Drugs
Cancer patients who attend FDA advisory committee meetings and address the panel during open comment periods often have financial ties with the company seeking marketing approval, and those ties aren’t always disclosed, according to an analysis appearing in JAMA Internal Medicine. “The industry has hijacked that microphone – they’re
FDA Policy/General
Positive feelings produced by images in direct-to-consumer drug ads can promote favorable beliefs about the drugs, according to research published online in Bioethical Inquiry (subscription or purchase required). Researchers from the U.S. and Australia say that their work shows that pairing a hypothetical influenza prescription medicine with
Drugs
A 6/3-6/24/15 FDA inspection at the Kirkman Laboratories drug manufacturing facility in Lake Oswego, OR, found that the company is marketing four unapproved new drugs, according to a 1/13 Warning Letter from the agency’s Seattle District Office. The document lists both unapproved new drug
Drugs
U.S. Representatives G. K. Butterfield (D-NC) and Susan Brooks (R-IN) have introduced HR 4400, a bipartisan bill that seeks to add Zika virus to the list of diseases included in FDA’s Tropical Disease Priority Review Voucher Program. The voucher program was enacted in 2007 to incentivize
Devices
Booz Allen Hamilton says that its evaluation of CDRH’s progress in implementing the consulting firm’s recommendations for improving the review of medical device premarket submissions shows that the Center successfully completed Stage 1 for each project in its Plan of Action to address the consulting firm’s recommendations.
Drugs
Yale Law School professor Amy Kapczynski says that a federal court decision in a suit brought by Amarin against FDA over dissemination of off-label information on its Vascepa in effect replaces drug regulators with judges, whose expertise in science and medical research varies considerably, when off-label promotion is
FDA Policy/General
Federal Register Notice: FDA seeks comments on the reporting requirements for submission and listing of patent information associated with a new drug application, an amendment, or a supplement. Comments should be submitted by 4/4. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: CDER and the Arthritis Foundation will co-sponsor a workshop 2/24-25 entitled, “Accelerating OA Clinical Trials Workshop.” Its purpose is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dechra Veterinary Products LLC Overland Park, KS (1/27) Unapproved new animal drug (levothyroxine products for dogs); FDCA 501 (a)(5) http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/
Drugs
FDA has approved a Bracco Diagnostics NDA for E-Z-HD, a barium-based contrast agent for use in double-contrast radiographic examinations of the esophagus, stomach, and duodenum to visualize the gastrointestinal tract in patients 12 years and older. This is the first regulatory approval of a barium-based