Latest Federal Register Notices

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: Amgen, Inc., v. Apotex, Inc., 15-cv-61631 (consolidated with 15-cv-62081, S.D. FL., filed 10/2/15). Under the Public Health Service Act, an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act and FDA is required to publish notice of the complaint in the Federal Register. To view this notice, click here.

DEVICES

FDA Issues EUA for Zika Virus Diagnostic
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. To view this notice, click here.

HUMAN DRUGS

CDER/C-Path Plan Workshop
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; uses of rodent and non-rodent nonclinical species in biomarker qualification; and assay validation aspects during biomarker development and qualification at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503 A/B), Silver Spring, MD. Contact Jacqueline Brooks-Leighton, (240) 402-5292. To view this notice, click here.

FDA Updates IND Regs
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. To view this notice, click here.

Pediatric Studies on Lorazepam Available
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 be submitted by 4/28. To view this notice, click here.

List of Info Collections Approved by OMB
Federal Register Notice: FDA is publishing a list of information collections Prescription Drug User Fee Cover Sheet; Form FDA 3397 and Food Additives; Food Contact Substances Notification System have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view this notice, click here.

Comments Sought on CLIA Waiver Info
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.

Comments Sought on OTC Drug Labeling
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 Renews Arthritis Panel Charter
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. 

VETERINARY

Animal Drug Regs Reflect 2015 Actions
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. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred 11/2015 and 12/2015. To view this final rule, click here.

FDA Corrects Animal Drug Reg Amendments
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)(3), remove “000859” and in its place add “069043.” To view this notice, click here.