FDA Policy/General
Federal Register Notice: FDA is extending the comment period to 6/30 for the document entitled “Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop,” that appeared in the 1/7 Federal Register. FDA requested comments on the appropriate level of good manufacturing practices regulation to ensure the
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 5/1/18. To view this notice, clickhere.
FDA Policy/General
DEVICES Biotronik has received FDA approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation that adapts the heart rate in response to
FDA Policy/General
BIOLOGICS FDA Proposes to Update Biological Standards Federal Register Proposed rule: FDA is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA aims to update outdated requirements, and accommodate new and evolving
FDA Policy/General
Federal Register Notice: The FDA commissioner renews the Pharmacy Compounding Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/25/18. To view this notice, click here.
FDA Policy/General
The Senate HELP Committee leadership has written FDA commisioner Robert Califf to communicate concern over the agency’s timeliness in finalizing or withdrawing draft guidance documents. In the 5/6 letter, the lawmakers criticize the agency for leaving companies in the dark to follow draft recommendations for years, “even if
FDA Policy/General
Federal Register Notice: FDA is making available grant funds to support FDA’s Office of Orphan Products Development Natural History Grants Program. The program’s goal is to support studies that advance rare disease medical product development through characterizing the natural history of rare diseases/conditions, identifying genotypic and phenotypic
FDA Policy/General
Federal Register Notice: FDA has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Such tests systems are used in diagnosing and treating carbohydrate
FDA Policy/General
Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation will hold a public workshop 6/1 entitled “Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics.” The objective of the workshop is to discuss quantitative and qualitative approaches for verifying
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Market Claims in Direct-to-Consumer Prescription Drug Print Ads has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. Its purpose is to assist sponsors in all phases of development of direct-acting antiviral drugs for treating chronic hepatitis C. It revises the draft
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Special Protocol Assessment. It provides information about the procedures and general policies adopted by CDER and CBER for special protocol assessment. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the general biological products standards relating to dating periods and also to remove certain standards relating to standard preparations and limits of potency. FDA aims to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public
FDA Policy/General
FDA says it has submitted to the Office of Management and Budget its data-gathering research proposal to investigate through direct-to-consumer print ads for prescription drugs the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. The submission contains comments
FDA Policy/General
Federal Register Notice: FDA has determined that several drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
FDA Policy/General
FDA associate deputy commissioner for medical products and tobacco Rachel Sherman and commissioner Robert Califf say there are several principles that must be kept in mind as interoperability and connectivity are used to build a national system for evidence generation. Writing in an FDA Voice blog post, they list the
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Apotheca Supply, Inc. dba Apothecares Decatur, AL (4/7). Inspected 2/10-12/15. CGMP deviations, adulterated: The firm’s quality unit failed to review and approve all quality
FDA Policy/General
Regen BioPharma has entered into a non-exclusive license agreement with Pan Am Cancer Treatment Center in Tijuana, Mexico to test HemaXellerate in a first-in-human proof of concept study. According to the company, HemaXellerate is comprised of cells extracted from the patient’s own fat tissue and processed
FDA Policy/General
BIOLOGICS CBER Releases eSubmitter Program for Vaccine AERS Federal Register Notice: CBER is making available a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. It is a free software
FDA Policy/General
FDA is developing a new genomics project called Sequencing Quality Control Phase 2 (SEQC2) that aims to develop quality control metrics and benchmark bioinformatics approaches for analyzing whole genome sequencing and targeted gene sequencing data. The project is also designed to achieve best practices, to develop standard analysis protocols, and
FDA Policy/General
Federal Register Notice: FDA is reopening the comment period and requesting public input on possible modifications to the current review processes for new animal drug applications for the use of multiple new animal drugs in combination drug medicated feeds. FDA is also making available a Center for Veterinary Medicine recommendations
FDA Policy/General
Federal Register Notice: CBER is making available a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products. It is a free software program for voluntary use that is intended to