FDA Policy/General
Workshop on Generating Real-World Evidence Federal Register notice: FDA announces a 7/12 public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” 06/07/2019 Nonalcoholic Steatohepatitis Drug Development Guide Federal Register notice: FDA makes available a draft guidance entitled “Nonalcoholic Steatohepatitis with
FDA Policy/General
DEVICES Medtronic has received approval from FDA for the Prestige LP Cervical Disc System for treating single-level cervical disc disease (radiculopathy and/or myelopathy). Quidel Corp. has received FDA clearance to market its AmpliVue GAS Assay for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic
FDA Policy/General
Sandoz has agreed to pay $12.64 million to settle allegations it misrepresented drug pricing data to the Medicare program. HHS Office of Inspector General (OIG) says the settlement is the largest ever entered into under its drug price reporting civil monetary penalty (CMP) authority. OIG alleged that between 1/
FDA Policy/General
Federal Register notice: FDA has announced a 7/12 public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” Convened by Duke University’s Margolis Center for Health Policy and supported by a cooperative agreement with FDA, the workshop is intended to bring the stakeholder
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment.” The document provides the agency’s current recommendations on important components of a drug development program for treating this condition. It focuses on enrollment criteria, trial design, efficacy endpoints, and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs.” The document recommends approaches that clinical trial sponsors can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations
Devices
Former Advanced BioHealing chairman and CEO Kevin Rakin has agreed to pay the government $2.5 million to settle False Claims Act allegations that he knowingly allowed company sales representatives to use kickbacks and other unlawful methods to induce clinics and physicians to use or overuse its Dermagraft product. The
Drugs
FDA has posted a 3/14 Warning Letter to Pharmasol after conducting two 8/2018 facility inspections at South Easton, MA and Stoughton, MA, and citing significant GMP violations at both. At both facilities, FDA said, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch
Drugs
FDA has approved two new methods for administering GlaxoSmithKline’s Nucala (mepolizumab) — an autoinjector and a pre-filled safety syringe — for patients with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis. This is the first anti-IL5 biologic to be licensed in the U.S. for
Drugs
The Federal Trade Commission (FTC) is implementing electronic filing to replace hard-copy submissions involving brand name and generic drug company agreements for antitrust reviews. Starting 6/17, such filings should be submitted to both the FTC at [email protected] and the Antitrust Division of the U.S. Department
Drugs
FDA has approved a PTC Therapeutics supplemental NDA for Emflaza (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy (DMD) who are between two and five years of age. Emflaza was first approved 2/2017 for treating Duchenne in patients five years and older. An agency news
Devices
FDA has cleared an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. “This device offers a safe
Drugs
Motif Bio says FDA is requiring an additional clinical trial before it can approve the company’s NDA for iclaprim, indicated for treating acute bacterial skin and skin structure infections. The agency expressed its position at a recent Type A meeting about a complete response letter that was issued in
Drugs
The Justice Department says Insys Therapeutics is settling separate civil and criminal investigations into illegal promotion of its Subsys opioid painkiller with a payment of $225 million. A department news release says the company will plead guilty to five counts of mail fraud and pay a $2 million fine and
Drugs
FDA has announced that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through CDER’s NextGen Portal. For sponsors already having a CDER NextGen Portal account, the account will be automatically updated with this pre-assigned ANDA number request functionality. To create
Devices
FDA has cleared an Akonni Biosystems 510(k) for its TruDiagnosis System, a compact point-of-service molecular diagnostic device which includes the TruDx 2000 Imager and the TruArray consumable test kit. The saliva test is intended to identify genetic signatures associated with patient metabolization of the drug Coumadin, which
Drugs
FDA has published a draft guidance, Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. The document contains the agency’s current recommendations on the important components of a drug development program for
Drugs
FDA is issuing a draft guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, to recommend approaches that NDA and BLA clinical trial sponsors can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their trials.
Devices
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) says doctors should not use paclitaxel drug-coated balloons or drug-eluting stents in routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk outweighs the benefits. An agency medical device alert says use of the
Drugs
FDA has accepted a Celgene NDA for ozanimod, indicated for treating patients with relapsing forms of multiple sclerosis (RMS). The oral, sphingosine 1-phosphate (S1P) receptor modulator binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The submission is based on data from the SUNBEAM and
Biologics
Responding to an FDA 5/28 Notice of Violation indicating that R3 Stem Cell, Scottsdale, AZ, was promoting regenerative stem cell therapies without an approved BLA, the company says it is reviewing its Web site and operations and is unaware of any safety issues resulting from stem cell contamination. “R3
Drugs
FDA has granted Palatin Technologies an orphan drug designation for PL-8177 for treating non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss, according to the company. PL-