Devices
CDRH will be seeking a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program. During a 10/27 public meeting on reauthorizing the user fees, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the
FDA Policy/General
The Justice Department has filed a civil complaint in a California federal court seeking a permanent injunction against Med-Pharmx and two individuals to prevent them from manufacturing and distributing animal drugs under conditions that fall short of the minimum regulatory requirements to ensure safety and quality. A Justice Department
Drugs
FDA has published a guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products, to give sponsors recommendations on the nonclinical information to support the development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. The document
Drugs
Four stakeholders are praising the FDA draft guidance on evaluating cancer drugs in patients with central nervous system (CNS) metastases and offering suggested changes. Bristol-Myers Squibb says the draft guidance is intended to provide clarity on study procedures and data requirements to support a label claim for benefit to
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date. The guidance revises FDA’s compliance policy on the deadline for filing PMA applications for previously cleared accessories necessary to operate automated external defibrillator systems. To view the notice, click
FDA Policy/General
Federal Register Notice: FDA has made available a final guidance entitled Referencing Approved Drug Products in Abbreviated New Drug Application Submissions. The document provides information to potential applicants on how to identify a reference listed drug, a reference standard, and the basis of submission in an ANDA submission. To view
Devices
FDA has released a summary of the 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligence and machine learning (AI/ML) in medical devices. The summary says the committee discussed the composition of the datasets on which the software “learns,” components of the
Drugs
CDER has issued a Manual on Policies and Procedures (MAPP), Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use: Responsibilities and Procedures, outlining policy, responsibilities, and procedures to be used in CDER for two types of
Devices
FDA has posted a revised guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency. The document expands the availability and capability of remote patient monitoring devices that may increase access to patient physiological data
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. The document provides information intended to assist applicants design and conduct such studies that may be submitted as part of a modified risk tobacco product application,
Devices
FDA’s Circulatory System Devices Advisory Panel has voted 13 to 3 against recommending PMA approval for Neovasc’s Reducer for treating patients with refractory angina pectoris despite guideline-directed medical therapy, and who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention. Several committee
Drugs
A 2/2-2/25 FDA inspection at the Shilpa Medicare Limited drug production facility in Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/9 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has published a guidance, Referencing Approved Drug Products in ANDA Submissions, providing information to potential applicants on how to identify a reference-listed drug (RLD), a reference standard, and the basis of submission in an ANDA. The document says a variety of factors has led to confusion among stakeholders
Devices
FDA says it will not enforce compliance with the PMA requirements for necessary automated external defibrillator (AED) accessories (such as batteries, pad electrodes, adapters, and hardware keys for pediatric use) until 2/3/22. An agency guidance, Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date, says the delayed enforcement
Drugs
Following the advice from an independent data and safety monitoring board, the National Institutes of Health (NIH) says no additional subjects will be enrolled in a clinical trial evaluating a Lilly investigational monoclonal antibody in hospitalized patients with Covid-19. The board made its recommendation based on a low likelihood
Drugs
The Washington, DC District Court has ruled that a recent FDA decision to remove a decades-old compliance policy affecting unapproved homeopathic drugs can be challenged in court. In Medinatura v. FDA, homeopathic product marketer MediNatura challenged the agency’s withdrawal of Compliance Policy Guide 7132.15, Section 400.400,
Drugs
A 2/4-3/13 FDA inspection at the KVK-Tech drug manufacturing facility in Newtown, PA, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/8 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures for cleaning and
FDA Policy/General
Federal Register notice: FDA has announced a 12/8-9 virtual public meeting entitled “The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security.” The meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss strategies
FDA Policy/General
Federal Register notice: FDA has announced a 12/16 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction. Data supporting the new indication are from post-hoc analyses of the National Heart, Lung, and
Drugs
Federal Register notice: FDA has announced a 12/15 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Novartis supplemental NDA for the angiotensin receptor-neprilysin inhibitor Entresto (sacubitril and valsartan) tablets for the proposed indication of heart failure with preserved ejection fraction. To view
Drugs
FDA has awarded a multi-year grant to the Critical Path Institute (C-Path) to advance standards and methodologies designed to generate real-world evidence from real-world drug data through a neonatal pilot project by the International Neonatal Consortium (INC). C-Path says the grant will support the collection
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. KVK-Tech, Newtown, PA (10/8): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, KVK-Tech failed to establish and follow