FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend its nonprescription (over-the-counter, or OTC) drug regulations. If finalized as proposed, the rule would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs,
FDA Policy/General
BIOLOGICS FDA Publishes Notice of Biosimilar Patent Infringement Action Federal Register Notice: FDA is publishing notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA. The agency has received notice of the following complaint:
FDA Policy/General
Dr. Reddy’s Laboratories and XenoPort have entered into a license agreement that grants Dr. Reddy’s exclusive U.S. rights for developing and commercializing XenoPort’s clinical-stage oral new chemical entity XP23829 for treating moderate-to-severe chronic plaque psoriasis. The therapy is also being considered for treating
FDA Policy/General
DEVICES Bracco Diagnostics has received FDA approval for Lumason for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients. The company says it is the first to receive approval for this clinical use of ultrasound contrast both in adults and children. CardioFocus
FDA Policy/General
Federal Register Notice: FDA is publishing notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA. The agency has received notice of the following complaint: Amgen, Inc., v. Apotex, Inc., 15-cv-61631 (consolidated
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget: Prescription Drug User Fee Cover Sheet; Form FDA 3397 and Food Additives; Food Contact Substances Notification System. To view this notice, click here.
FDA Policy/General
Federal Register Correction: FDA corrects a 3/30 Federal Register rule, which amended the animal drug regulations to reflect 11-12/2015 NADA and ANADA approvals and to make technical amendments. On page 17608, change amendatory instruction 33 to read as follows: 033. In Sec. 524.1044g, in paragraph (b)
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has objected to a Shionogi “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion because it omits important risk information associated with the use of Ulesfia and omits material facts. As such, the voucher misbrands Ulesfia and makes its distribution violative,
FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee has planned a 4/6 mark-up for five FDA/biomedical innovation bills. This follows a 3/9 mark-up that favorably voted out seven bipartisan bills on biomedical innovation and seven previous bills voted out 2/9 (see earlier story). The
FDA Policy/General
Federal Register Notice: FDA is seeking comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications. Comments should be submitted by 5/31. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the standardized format and content requirements for the labeling of over-the-counter drug products. Comments should be submitted by 5/31. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/18. To view this notice, click here.
Drugs
The Justice Department says Novartis has violated a Corporate Integrity Agreement it signed following the $422.5 million settlement of a 2010 case against the company over its drug promotional practices, and should now be hit with each tougher penalties. The government says the company engaged in a nationwide kickback
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during 11/2015 and 12/2015. The agency is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
FDA Policy/General
FDA commissioner Robert Califf says that one of his highest priorities in leading the agency is to encourage and support a professional environment that enables the staff to thrive and to reach its full potential. Writing in an FDA Voice blog post, Califf says that his workforce initiative is intended
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket to make available to the public a report of the pediatric studies of lorazepam that were conducted in accordance with the Public Health Service Act and submitted to the director of the National Institutes of Health and FDA commissioner. Comments should
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket to make available to the public a report of the pediatric studies of lorazepam that were conducted in accordance with the Public Health Service Act and submitted to the director of the National Institutes of Health and FDA commissioner. Comments should
FDA Policy/General
FDA announced 3/29 the first simultaneous review and approval of a new drug for food-producing animals by the agency's Center for Veterinary Medicine (CVM) and Health Canada. The drug, Eli Lilly Elanco Animal Health's Imrestor (pegbovigrastim injection), is intended to reduce the incidence of
FDA Policy/General
Today FDA posted its latest batch of Warning Letter. They can be accessed by clicking on the link following each letter. Leiter’s Compounding San Jose, CA (2/29). Inspected 9/15/14-10/7/14. CGMP deviations, adulterated: The facility failed to submit a report to FDA upon initial
FDA Policy/General
Federal Register Notice: CDER and the Critical Path Institute will co-sponsor a public scientific workshop 4/25 from 8:30 a.m. to 5 p.m. Its purpose is to discuss the following issues: Application of toxicometrics as a translational safety strategy that integrates nonclinical and clinical safety approaches;
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for diagnosis of Zika virus infection in response to the Zika virus outbreak in the Americas. The authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device.
FDA Policy/General
Federal Register Final rule: FDA is amending its regulations to update the address for applicants to submit investigational new drug applications for biological products regulated by CDER. FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems to correct a typographical error.