Drugs
Mallinckrodt has completed a rolling NDA submission for terlipressin, an investigational agent being evaluated for treating hepatorenal syndrome Type 1 (HRS-1). HRS-1 is a life-threatening condition involving acute kidney failure in people with cirrhosis. In 2016, Mallinckrodt and the agency reached agreement on the Phase 3 CONFIRM
Devices
CME America has recalled its BodyGuard Microset Infusion Sets due to potential medication flow restrictions. Certain sets (catalog number A120-003XYVA) have an extended section of tubing longer than standard lengths, which can restrict medication flow to the pumping chamber of the infusion pump, according to a recall notice. (XXINSERT
FDA Policy/General
Due to coronavirus concerns, FDA 3/18 “temporarily postponed” all domestic routine surveillance facility inspections to protect the “well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors.” An FDA notice says that “all
Drugs
FDA has issued an immediately-effective guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products during the Covid-19 Pandemic, to help clinical trial sponsors assure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity during the Covid-19 pandemic.
Drugs
In a 2-1 ruling, the Court of Appeals for the DC Circuit has said that Eagle Pharmaceuticals deserves a seven-year orphan drug exclusivity for its Bendeka (bendamustine HCl). FDA approved Bendeka for marketing in 2015 but denied exclusivity because it said the company failed to prove that it
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has identified areas in an FDA draft question-and-answer guidance on pediatric study plans for oncology drugs before full implementation of section 504 of the FDA Reauthorization Act (FDARA) that would benefit from further discussion, confirmation, clarification, and/or revision
Drugs
Ropes & Gray says that a recent federal court ruling may require clinical trial sponsors to report a decade’s worth of previously exempted data to ClinicalTrials.gov. “If the government allows the ruling to take effect without appealing, or if it is upheld on appeal, this decision could prove
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.” The document provides recommendations on using restricted delivery systems to limit unintentional ingestion of oral liquid drug products (e.g., oral solution, oral suspension) by children. The recommendations apply
Drugs
A Louisiana federal judge has ruled that design defect and failure-to-warn claims brought against a gadolinium contrast agent manufacturer are preempted by federal law. Attorney Steven Boranian (Reed Smith) says the decision is a good example of how preemption should work. Writing in the Drug and Device Law
FDA Policy/General
Federal Register notice: FDA has debarred Jagen Lewicki for five years from importing or offering for import any drug into the U.S. Lewicki was convicted for conspiracy to distribute human growth hormone imported from China for a purpose other than treating a disease. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has debarred Matthew Dailey for 10 years from importing or offering for import any drug into the U.S. Dailey was convicted for introducing misbranded drugs into interstate commerce and one felony count of importing merchandise contrary to law. He imported hundreds of shipments of kratom,
Drugs
President Trump says he has asked FDA to cut through “red tape and reduce regulatory barriers,” presumably to advance products associated with the coronavirus outbreak. During a virus press briefing at the White House 3/18, Trump said: “We’re looking at some very exciting things ... some things are happening
Drugs
CDER’s Office of New Drugs (OND) has denied an Acer Therapeutics appeal of a 6/2019 complete response letter on an NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syndrome (vEDS). The letter said it was necessary to conduct an adequate and well-controlled trial to “determine whether
Drugs
Janssen Pharmaceutical has submitted an NDA for ponesimod for treating adult patients with relapsing multiple sclerosis (MS). The selective sphingosine-1-phosphate receptor 1 (S1P1) modulator inhibits S1P protein activity, which is believed to reduce the number of circulating lymphocytes that can cross the blood-brain barrier, the company says.
Drugs
A 9/16-9/27/19 FDA inspection at Cipla Limited, Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/25 Warning Letter says the specific violations were: * failing to clean, maintain, and, as appropriate for the nature of the
Drugs
FDA has released a 1/17 Warning Letter sent to Gojo Industries, Cuyahoga Falls, OH, asserting that because the firm’s Purell Healthcare Advanced Hand Sanitizer product line is intended for use as consumer and healthcare antiseptics it is considered an unapproved new drug. The letter contains examples of claims
Drugs
FDA has issued a draft guidance, Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products, to help manufacturers of oral liquid drug and biological products use restricted delivery systems to limit unintentional ingestion of oral liquid drug products such as oral solution and oral suspension by children. The document
Drugs
An 8/26-8/30/19 FDA inspection at Windlas Healthcare Private Limited, Dehradun, Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were: * failing to ensure that laboratory records included complete data derived from all
Drugs
FDA has postponed the 4/16 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee due to the coronavirus health emergency. Panel members were scheduled to review a TransMedics PMA for the TransMedics Organ Care System — Heart, a portable ex-vivo organ perfusion and monitoring system
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports. The products withdrawn are Pan American Laboratories’ Maolate (chlorphenesin carbamate) tablet, 400mg, Iomed’s Iontocaine (epinephrine and lidocaine hydrochloride) topical solution, and Vyteris’ LidoSite Patch (lidocaine HCl and
Drugs
FDA has updated a policy issued last month on diagnostic testing for coronavirus to expand the number and variety of diagnostic tests available in health care settings, and reference and commercial laboratories. The updated policy allows states to take responsibility for tests developed and used by laboratories in their states,
FDA Policy/General
Federal Register: FDA has debarred Zhang Xiao Dong for five years from importing articles of food (including dietary supplements) or offering such articles for importation into the U.S. Dong was convicted for selling synthetic stimulant ingredients to a dietary supplement manufacturer, knowing that the ingredients would be omitted from