Drugs
FDA has published a guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application, to help applicants determine which of the abbreviated approval pathways is appropriate for submission of a marketing application to the agency. The document says that many potential drug product developers are not familiar
Devices
FDA has granted de novo marketing clearance to KCI for Prevena Incision Management System, a negative pressure medical device indicated to aid in reducing superficial surgical site infections in patients at a high risk for post-operative infections in Class 1 and 2 wounds. The device is also intended to
Devices
FDA has granted Farapulse a breakthrough device designation for its Farapulse Pulsed Field Ablation System and its use in treating drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The device uses non-thermal energy to create durable lesions to improve the safety profile of cardiac ablation. It is intended to offer
Drugs
A Supreme Court decision expected in June could lead to an increase in False Claims Act cases according to some attorneys contacted by Bloomberg Law. The report says that defense attorneys “resoundingly believe [the ruling] will give whistleblowers more time to act on behalf of the government and sue companies
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking FDA to clarify a draft guidance on principles of premarket pathways for combination products. The association says that while it appreciates the agency’s efforts to clarify the premarket pathways for combination products and implement provisions of the 21st Century Cures
Drugs
The International Council for Harmonization has released for public comments a revised draft guideline entitled “General Considerations For Clinical Studies E8(R1).” The document focuses on designing quality into clinical studies and it is intended to: * Describe internationally accepted principles and practices for designing and conducting clinical studies that will
Drugs
Bristol-Myers Squibb says its Phase 3 CheckMate-498 trial evaluating Opdivo (nivolumab) plus radiation versus temozolomide plus radiation in patients with newly diagnosed O6-methylguanine-DNA methyltransferase-unmethylated glioblastoma multiforme did not meet its primary endpoint of overall survival at final analysis. The drug’s safety profile was consistent
Drugs
FDA has issued a guidance, Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations, to assist sponsors in evaluating reproductive toxicity (mainly for effects on embryo-fetal development, or EFD) for oncology pharmaceuticals. The document also is intended to provide recommendations for product labeling on duration of contraception following cessation of
Drugs
FDA has published a draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics, to encourage sponsors and applicants who are using real-world data to generate real-world evidence (RWE) as part of their regulatory submission to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Experimental Study of an Accelerated Approval Disclosure.” The study is intended to examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer promotional materials. This
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities.” The federal Food, Drug, and Cosmetic Act requires FDA to develop a list of bulk drug substances that may be used in compounding.
Drugs
FDA is issuing two draft guidances that, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information on drugs used during pregnancy or lactation. The first draft, Clinical Lactation Studies: Considerations for Study Design, gives agency recommendations for sponsors on
Drugs
FDA has just released the Establishment Inspection Report (EIR) from an 8/6-8/14/18 inspection at Immunomedics, Morris Plains, NJ. The EIR says a 13-item FDA-483 was issued to the company at the close of the inspection with these observations: * the quality control unit lacks authority
FDA Policy/General
The HHS Centers for Medicare and Medicaid Services has finalized a rule requiring direct-to-consumer TV ads for prescription drugs covered by Medicare or Medicaid to include the list price — defined in the rule as the wholesale acquisition cost — if that price is equal to or greater than $35
Devices
Johnson & Johnson’s DePuy unit has agreed to pay about $1 billion total to resolve most of the lawsuits claiming the company sold defective metal-on-metal hip implants that ultimately had to be removed. Bloomberg Technology reported the agreement would resolve more than 95% of the 6,000
Drugs
The Biotechnology Innovation Organization (BIO) says it is pleased that FDA has included in a draft guidance on nonproprietary naming of biological products use of a four-letter distinguishable suffix for biological products. “BIO shares FDA’s view that a distinguishable nonproprietary naming convention will best facilitate robust pharmacovigilance, promote
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