Drugs
The House has passed two bipartisan bills that would make updates to FDA’s Orange Book and Purple Book to improve accuracy and transparency of the two databases that guide development decisions for generic and biosimilar manufacturers. They are: H.R. 1503, the Orange Book Transparency Act of 2019, from
Devices
FDA has cleared two CryoConcepts 510(k)s for cryosurgical devices for physicians. The CryoTouch is a portable device that delivers cryogen to lesion sites and can use either applicators or cones based on a physician’s preference. The CryoLab is a benchtop unit that delivers cryogen for medical practices
Devices
FDA has cleared a BioCardia 510(k) for the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The company says the device is “virtually whipless around curves due to their helically arranged
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Utilizing Animal Studies to Evaluate Organ Preservation Devices.” The document recommends balancing the ethical principles of replacement, reduction, and refinement as well as regulatory least burdensome principles, with the goal of using the minimum number of animals necessary to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D.” To view the notice, click here.
Devices
FDA has already approved so-called “locked” medical devices that rely on artificial intelligence, and now is trying to determine how to certify devices that learn and evolve. Roll Call reports the agency is weighing how to assess and certify devices powered by artificial intelligence that continuously adapt to new
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy Clarification for Certain Fluoroscopic Equipment Requirements.” The document is intended to clarify FDA’s interpretation of certain aspects of the performance standard requirements for fluoroscopic equipment. To view the notice, click here.
Drugs
Pharmaceutical recalls decreased 7.8% to 94 in the first quarter of 2019, higher than 19 of the last 21 quarters, according to the Stericycle 2019 Q1 index. The report says that recalled units decreased 75.3% to just under 13 million, lower than six of the last nine quarters.
Drugs
A 9/17-9/21/18 FDA inspection at Laboratoires Clarins, Pontoise, France, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 4/23 Warning Letter lists specific violations as: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Devices
FDA has issued a final guidance, Utilizing Animal Studies to Evaluate Organ Preservation Devices, to provide recommendations on best practices for using animal studies to evaluate organ preservation devices. The document says the agency recommends balancing the ethical principles of replacement, reduction, and refinement as well as regulatory least burdensome
Devices
FDA has issued a safety alert on certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) about issues that may cause their batteries in to drain more quickly than expected without warning patients or health care providers. The agency says it has received three medical device reports in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).” The document describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission standards during laser product classification under the Electronic Product
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Laser Products — Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1(Laser Notice No. 56).” The document is intended to describe the agency’s approach to compliance with FDA’s performance standards for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Medical X-Ray Imaging Devices Conformance with IEC Standards.” The document describes FDA’s policy on the regulation of medical x-ray imaging equipment that is subject to the agency’s medical device and electronic product regulations. To view
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is proposing to research the presence, wording, and prominence of a disclosure communicating information related to a drug’s accelerated approval in direct-to-consumer promotional materials. A 5/8 Federal Register notice says FDA requires that the Indications and Usage section
Drugs
Drug companies are making significant use of artificial intelligence (AI) in drug development, and use of AI is expected to grow as companies seek novel approaches to drug development and encounter growing competition in various disease areas. That’s the major takeaway from a Tufts Center for the Study of
Drugs
FDA has released the FDA-483 issued following a 4/8-4/16 inspection at Torrent Pharmaceuticals, Indrad, Gujarat, India. The four inspection observations on the form were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Devices
Recros Medica has filed a de novo regulatory submission for the Nuvellus Focal Contouring System. The device uses the company’s “Rotational Fractional Resection” technology to provide medical aesthetic physicians a single treatment option to improve submental (neck and jowl) contouring. “Nuvellus is a novel alternative to current skin contouring
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Laboratoires Clarins, Pontoise, France (4/23): FDA inspected the firm 9/2018 and cited significant GMP violations with finished pharmaceuticals. For example,
Devices
FDA has cleared a Rapid Medical 510(k) for its Comaneci Temporary Coil Embolization Assist Device. The company describes it as the first adjustable, fully-visible aneurysm remodeling device. It is intended to act as a temporary bridge used to aid in the coiling processes while minimizing the risk of
FDA Policy/General
Federal Register notice: FDA has announced a 6/20 meeting of the Oncologic Drugs Advisory Committee’s Pediatric Oncology Subcommittee. During the morning session, panel members will review and discuss two pediatric molecular targets: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in
Drugs
FDA has approved Pfizer subsidiary FoldRx’s NDAs for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for treating heart disease caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. An FDA release says these are the first FDA-approved treatments for ATTR-CM. “Vyndaqel and Vyndamax have the same active