Department of Health and Human Services August 2020 – Federal Register Recent Federal Regulation Documents
Results 251 - 256 of 256
Watson Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets. The basis for the withdrawal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA. The holder of the ANDA has waived its opportunity for a hearing.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2021
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2021 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2021.
Generic Drug User Fee Rates for Fiscal Year 2021
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2021 rates for GDUFA II fees.
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices
The Food and Drug Administration (FDA, the Agency, or we), with the Department of the Treasury's concurrence, is proposing to amend its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by U.S. Customs and Border Protection (CBP), in order for CBP to process the filing and to help FDA in determining the admissibility of that veterinary device. The proposed rule would make the submission of the general data elements currently required to be submitted in ACE for other FDA- regulated products at the time of entry also required in ACE for veterinary devices being imported or offered for import into the United States. This proposed rule would increase effective and efficient admissibility review by FDA of those entry lines containing a veterinary device, which will protect public health by allowing the Agency to focus its limited resources on FDA-regulated products that may be associated with a greater public health risk.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
