Drugs
FDA has issued a draft guidance, Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in complying with certain labeling requirements for human prescription drug and biological products. The document provides recommendations for
FDA Policy/General
Federal Register notice: FDA has permanently debarred William Ralph Kincaid from providing services in any capacity to a person that has an approved or pending drug product application. The debarment is based on Kincaid’s felony conviction in 2013 after pleading guilty to receiving in interstate commerce a misbranded drug
Devices
FDA has issued a draft guidance, Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56), describing the agency’s proposed approach regarding compliance with its performance standards for laser products. “Because conformance to certain comparable portions of IEC
Drugs
Gilead is asking the Supreme Court to hear its appeal of a 9th Circuit Court of Appeals decision in a False Claims Act (FCA) case involving several of its HIV drugs that the company says is inconsistent with the Supreme Court decision in a 2016 case (Escobar) involving a question
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Forest Laboratories’ Avycaz (ceftazidime pentahydrate and avibactam sodium) was 2,579 days. Of this time, 2,333 days occurred during the testing phase and 246 days occurred during the approval phase. The product is
Drugs
FDA has accepted for review an Aquestive Therapeutics NDA for clobazam oral soluble film (OSF) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. LGS accounts for about 4% of all cases of childhood epilepsy. The agency has set a
Drugs
Three Jones Day attorneys say in an online blog post that the 2nd Circuit Court of Appeals has joined several other circuits in enforcing the “rigorous” materiality standard for False Claims Act cases set forth by the Supreme Court in its 2016 Escobar decision. The 2nd Circuit ruled in a
Devices
FDA has cleared a Centric Medical 510(k) for the Cannulated Screw Internal Fixation System for use in foot and ankle reconstruction procedures. The company says the streamlined multi-component system is made of titanium alloy and comes in a variety of diameters and lengths (2.0, 2.5, and
Drugs
FDA has issued two guidances with drug compounding definitions and one guidance on mixing, diluting, or repackaging biological products outside the scope of an approved BLA. The first compounding guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food,
Drugs
FDA has granted Lyric Pharmaceuticals a fast track designation for ulimorelin (LP101) for treating enteral feeding intolerance (EFI) in critically ill patients. Ulimorelin, a macrocyclic agonist of the hormone ghrelin, is under clinical development for treating EFI and for other disorders affecting critically ill patients in intensive care units (ICU)
FDA Policy/General
FDA has issued a draft guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, to assist and provide recommendations about the use, content, and circumstances for issuing public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart
Drugs
FDA says it believes the public would benefit from having recall information about FDA-regulated products as soon as possible, even if more agency evaluation and classification of a recall remains to be done. Office of Enforcement and Import Operations director Douglas Stearn writes in an FDA Voice blog post
Drugs
FDA has released the FDA-483 issued following a 12/6-12/13/17 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. The four inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions; * aseptic processing areas
Drugs
FDA commissioner Scott Gottlieb has released the agency’s 2018 Compounding Policy Priorities Plan that he describes as a “comprehensive work plan for how we will implement key aspects of this important law, including making changes to some proposed policies to better ensure we balance the need to preserve access
Drugs
HHS and 15 other federal agencies say they are delaying for six months from 1/19 to 7/19 the general compliance date for 2018 revisions to the Federal Policy for the Protection of Human Subjects that is in a final rule published 1/19/17. A Federal Register notice
Drugs
FDA says AuroMedics Pharma is recalling one lot of levofloxacin in 5% dextrose injection 250mg/50mL in a single-use flexible container that has been found to contain visible particulate matter tentatively identified as mold. An agency statement says the problem was discovered as a result of a product complaint
Drugs
Almost half of FDA employees would be ordered to stay home under a current budget impasse if Congress and president Donald Trump can’t come to terms by midnight 1/19 on funding for fiscal year 2018. It is possible that a continuing resolution could be negotiated that would delay
Devices
FDA has cleared an International Biophysics 510(k) for the FloPump 32 centrifugal disposable heart pump. The company says the single-use device is one of the smallest centrifugal pumps in the world at 32ml prime, and it is intended to be used in conjunction with the Maquet RotaFlow console.
Devices
FDA has cleared a Medtronic 510(k) for the Riptide Aspiration System for use in retrieving blood clots through the Arc catheter and restoring blood flow in patients experiencing blockage of an artery in the brain (ischemic stroke). The procedure involves inserting a catheter through an incision in the leg
Drugs
Three FDAers say many researchers are unaware of FDA regulatory science research opportunities and the need for collaboration. Writing in Trends in Pharmaceutical Sciences, the three say the agency has “multiple avenues for collaborative research including participation in public-private partnerships, working with consortia, implementation of research collaboration agreements with
FDA Policy/General
The Senate Finance Committee voted 15-12 to recommend to the full Senate the nomination of Alex Azar as HHS secretary, succeeding Tom Price, who was forced to resign after reports that he routinely flew in chartered jets at taxpayer expense. Observers believe Azar will win the nomination in the
Devices
An FDA safety alert is warning health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying a “call for service” message code 102. Failure to