Devices
The Government Accountability Office (GAO) says FDA should develop a policy for using enforcement discretion regarding unauthorized diagnostic tests in future public health emergencies. “This policy should include the conditions under which FDA would begin and end the use of such discretion,” a GAO report says. GAO says it was
Drugs
India’s troubled Aurobindo Pharma says a 5/2-5/10 FDA inspection at its Unit VII oral drug manufacturing facility in Jedcherla, Hyderabad, resulted in an FDA-483 with six observations.In a submission to the National Stock Exchange of India, Aurobindo says it will respond to FDA within
Drugs
The U.S. now has a sufficient supply of molybdenum-99 (Mo-99) produced without highly enriched uranium, thanks to efforts by FDA and other government and private organizations. In a CDER From Our Perspective online post, Division of Imaging and Radiation Medicine medical officer Joseph Rajendran says the Center
FDA Policy/General
FDA has published an Enterprise Modernization Action Plan (EMAP) as an agency-wide business process, data, and IT (information technology) management approach that will allow the agency to better leverage the vast amount of data that is the foundation of its work. An initial document says the three components of
Drugs
FDA has extended by 90 days its review period for an Amicus Therapeutics BLA for cipaglucosidase alfa and its NDA for miglustat, the two components in the company’s AT-GAA, intended for late-onset Pompe disease. The new PDUFA action dates for the BLA and NDA are 8/29
Devices
Medical device manufacturers should pay close attention to cybersecurity regulatory and legislative developments, expand their internal expertise, and otherwise invest in establishing robust cybersecurity risk assessment, design control, and risk management practices and procedures relating to their devices. That’s the advice of Ropes & Gray attorneys in an online
Drugs
Sanofi and AstraZeneca say a pre-specified pooled analysis of Phase 3 and Phase 2b data demonstrates efficacy of 79.5% for their nirsevimab against medically attended lower respiratory tract infections, including hospitalizations, caused by the respiratory syncytial virus (RSV). A Sanofi media statement says the safety profile across the
Devices
FDA has posted a redacted surgical mask 510(k) review memo to assist third-party review organizations. An agency notice says FDA cannot share proprietary information but is creating a library of redacted memos for selected medical devices with a high volume of third-party reviews.
FDA Policy/General
Federal Register notice: FDA is denying a debarment hearing request from Marwan Massouh and is issuing an order debarring him for three years from providing services related to an approved or pending drug product application. Massouh pled guilty in 2013 to purchasing oncology drugs from a drug distributor located in
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/3/2024. To view the notice, click here.
Drugs
Veru Inc. says it will submit an emergency use authorization (EUA) application in the second quarter of 2022 for its sabizabulin for use in hospitalized moderate-to-severe Covid-19 patients at high risk for acute respiratory distress syndrome. A company statement says a 5/10 pre-EUA conference with
Drugs
A 5/9-concluded FDA inspection of Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India) resulted in a 10-item Form FDA-483, according to a company release. Sun says it is preparing a response to the observations, which will be submitted to the agency within 15 business days. The
FDA Policy/General
In a rare exhibition of bipartisanship, the House Energy and Commerce Committee 5/11 unanimously voted (30 to 0) to advance a legislative package that would reauthorize FDA user fees for an additional five years and enhance several FDA programs. The package now heads to the full committee for consideration
Biologics
FDA has approved an ADMA Biologics request to extend the expiration date from 24 to 36 months for Bivigam (immune globulin intravenous), indicated for treating primary humoral immunodeficiency. An FDA notice says the new expiration date is valid for 120 Bivigam lots that were manufactured and distributed in 2020-2022.
Drugs
Eisai has completed a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril antibody lecanemab (BAN2401) for treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD with a confirmed presence of amyloid pathology in the brain. Eisai has requested a
Biologics
CBER has updated its calendar year 2022 guidance agenda to list 17 guidances the Center is considering for development this year. The revised agenda lists eight topics under Blood and Blood Components, seven topics under Tissues and Advanced Therapies, and two topics under Vaccines. The previous agenda projected 13 guidances,
Devices
In a Regulatory Affairs Professional Society interview, outgoing FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional Congressional authorities for its digital health products pathway and other digital programs. In the online interview, he said the authorities FDA needs include being able to use real-
FDA Policy/General
Federal Register notice: FDA has determined that Pfizer’s Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Glucotrol is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Benefit-risk Considerations for Product Quality Assessments.” The document discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA’s understanding of the potential effect
Drugs
An 8/5-9/16/21 FDA inspection at Brigham and Women’s Hospital, Boston, MA, found significant violations of current good manufacturing practice regulations for positron emission tomography drugs. A 4/11 Warning Letter says specific violations were: * the facilities are not adequate to ensure the prevention of equipment
Drugs
CDER says it has launched its new Accelerating Rare disease Cures (ARC) program to speed and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. An online announcement says developing drugs for some 7,000 rare diseases and conditions can be
Drugs
Mesa Biotech has recalled (Class 1) its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive results due to contamination at the manufacturing facility. False positive results could lead to further exposure of uninfected individuals to Covid-19, according to