Drugs
Four Alston & Bird attorneys say there is bipartisan support in both the House and Senate for the PDUFA 7 reauthorization legislation. Writing in a Health Care Legislative and Public Policy Advisory, the attorneys review some of the key provisions of the legislation. They report that PDUFA 7 places greater
Drugs
Pfizer says that as a result of a very low rate of death or hospitalization observed in standard risk Covid-19 patients, it will stop enrolling patients into the EPIC-SR trial of Paxlovid (nirmatrelvir [PF-07231332] tablets and ritonavir tablets). A statement says the company will include available data
FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee late 6/14 passed in a 13 to 9 vote the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the agency’s prescription drug, generic drug, biosimilar, and medical device user fee agreements for another five years beginning 10/1. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry entitled “Q9(R1) Quality Risk Management (QRM).” The International Council for Harmonization document is a targeted revision of a 2006 guideline. It addresses four areas for improvement, including high levels of subjectivity in risk assessments and in QRM
Drugs
CDER director Patrizia Cavazzoni is personally spearheading CDER’s new rare disease efforts under its recently announced Accelerating Rare disease Cures (ARC) program, which is designed to speed and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. Delivering a Center
Biologics
FDA has published a draft guidance, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, describing a CBER program designed to identify and recognize voluntary consensus standards to facilitate the development and assessment of regenerative medicine therapy products regulated by the Center. The document says CBER encourages the use of
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted 6/15 to recommend the agency expand the Covid-19 vaccine emergency use authorizations (EUA) for Pfizer-BioNTech and Moderna to allow their use in children as young as six months of age. Panel members concluded that the Pfizer-
Devices
FDA has published a guidance, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions, with recommendations for manufacturers about information that should be in premarket submissions for radiological devices that include quantitative imaging functions. The document clarifies that, in general, manufacturers preparing premarket submissions (PMA, HDE, 510(k)
FDA Policy/General
The Alliance for a Stronger FDA says it supports the FY 2023 FDA funding proposed in legislation marked up on 6/15 in the House Agriculture Appropriations Subcommittee. The Alliance says the agency would receive $3.645 billion in discretionary budget authority funded in the bill, an increase of $341
Drugs
The American Medical Association (AMA) is encouraging FDA to approve over-the-counter (OTC) access to oral contraceptives without an age restriction. A statement issued during the AMA annual meeting says an FDA regulatory pathway exists for converting oral contraceptives from prescription products to OTC products and a required manufacturer
Drugs
An 8/4-8/20/21 FDA inspection at ACRC Studies, Poway, CA, conducted by Dr. Smitha Reddy, found “objectionable conditions” in the conduct of two clinical investigations. A 5/27 Warning Letter says the inspection was part of the agency’s Bioresearch Monitoring Program. The letter says a review
Drugs
A 7/27-9/3/21 FDA inspection at Hybrid Pharma, a Deerfield Beach, FL, outsourcing facility, determined that drug products produced there failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to be exempt
Drugs
FDA has approved an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three months for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Approval was based on nine-month data from the HELIOS-A Phase 3 study that showed the therapy significantly
Drugs
Three Troutman Pepper attorneys say a 4/14 FDA draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials, is the agency’s first attempt to articulate detailed expectations for submission of a plan by trial sponsors to ensure that clinical trial
Drugs
FDA presiding officer Celia Witten says she expects an FDA advisory committee hearing on whether agency approval for Covis’ Makena (hydroxyprogesterone caproate injection) should be withdrawn will be held 10/17-10/19. The hearing dates are included in a letter to attorneys for CDER and Covis providing the questions
Drugs
A Brookings Institution white paper says there are steps FDA could take to better promote generic competition. The paper focuses on three areas of FDA authority that Brookings says “could be refined to better promote generic competition: the Citizen Petition mechanism, the approval of so-called complex generic drugs, and
FDA Policy/General
FDA commissioner Robert Califf does not think a total revamp of the drug accelerated approval program is needed in response to criticism that followed a number of drug indications being withdrawn because companies were unable to generate confirmatory effectiveness data. Delivering the commissioner’s address at the Food and Drug
Drugs
FDA and the Organization of Economic Cooperation and Development are launching an initiative to encourage the wide-scale adoption of a “whole-of-governments” approach to combating illicit medical products. A joint announcement says the initiative started with a 5/24 non-public meeting that focused on a successful whole-
Devices
FDA says it has contracted with Research Triangle Institute International to study how patients weigh the benefits and risks associated with smooth and textured breast implants. An agency announcement says CDRH believes the survey results will help assess whether patients’ perception of the risk of breast implant-associated anaplastic large
Biologics
An FDA advisory committee 6/14 voted unanimously (22 to 0) to recommend the agency grant Moderna an emergency use authorization for its Covid-19 vaccine in children aged six months to 17 years. An FDA briefing document showed that vaccine efficacy was 93.3% for participants 12-17 years
Drugs
FDA has published a draft International Council for Harmonization (ICH) guidance, Quality Risk Management Q9 (R1), to provide a systematic approach to quality risk management for better, more informed, and timely decisions. The ICH says the document “serves as a foundation or resource document that is independent of, yet supports,
Devices
FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have undergone cardiothoracic surgery using the devices. The agency says that last month it cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow