Devices
FDA has approved an Impulse Dynamics PMA for the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The device comprises
Drugs
FDA has granted Enzyvant rare pediatric disease and fast track designations for RVT-801, an investigational enzyme replacement therapy. RVT-801 was previously granted an orphan drug designation and is currently in preclinical development for Farber disease, a rare condition for which there are no approved treatments. RVT-801 is
Drugs
Novo Nordisk has submitted two NDAs to FDA for oral semaglutide, the first once-daily glucagon-like peptide-1 receptor agonist in a pill. The company says one NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with Type 2 diabetes.
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5
Drugs
FDA Anesthetic and Analgesic Drug Products Advisory Committee chair Raeford Brown, a University of Kentucky professor, and Public Citizen Health Research Group founder and senior advisor Sidney Wolfe are calling on HHS and FDA to immediately impose a moratorium on FDA approval of any new or reformulated opioids. The two
Drugs
CDER director Janet Woodcock says the Center reorganization first announced 7/2018 has been approved. “The reorganization aims to transform and strengthen the way FDA fulfills its public health and regulatory role,” she says in a staff memo. The organizational changes take effect 3/31. The changes involve the Office
Devices
Soliton has submitted a 510(k) for the Rapid Acoustic Pulse (RAP) tattoo removal device. The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. The company says
Drugs
FDA imposed its most restrictive distribution program on the nation’s first postpartum depression (PPD) drug for adult women, Sage Therapeutics’ intravenous Zulresso (brexanolone). The severe restrictions in its Risk Evaluation and Mitigation Strategy (REMS) is due to concerns about serious risks, including excessive sedation or sudden loss of consciousness
Drugs
The DC federal court has granted an FDA motion for a voluntary remand of Vanda Pharmaceuticals’ suit challenging the agency requirement to perform nine-month large animal studies of its tradipitant before beginning studies in humans. (Tradipitant is a potential treatment for several human conditions including gastroparesis). The court declined
FDA Policy/General
Oregon attorney general Ellen Rosenblum says Pfizer will pay $975,000 to settle state charges that it distributed misleading marketing materials and coupons to Oregon consumers. Rosenblum says the coupons were designed to help consumers afford copays or deductibles associated with branded drugs. Some $620,000 of the settlement money
Drugs
A Shanghai, China business owner has been sentenced in Dallas to 18 months imprisonment and one year of supervised release in connection with a scheme to sell mislabeled dietary supplements. Xu Jia Bao (aka Fred Xu) is the principal of Shanghai Waseta International Trade Co. Ltd., a Chinese firm that
Devices
Symantec says the current iteration of an FDA draft guidance on content of premarket submissions for managing cybersecurity in medical devices has “significant improvements over the previous version and helps align stakeholders to the shared mission of providing a more secure and safer healthcare system.” In a comment letter, the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric HIV Infection: Drug Product Development for Treatment.” The document provides general recommendations for developing antiretroviral drug products for treating human immunodeficiency virus infection in pediatric patients. It also addresses when to initiate pediatric formulation development and begin pediatric
Drugs
HHS’s Centers for Medicare & Medicaid Services (CMS) has submitted to OMB for review 3/18 a proposed rule to require including drugs’ list prices in direct-to-consumer (DTC) advertising. The OMB submission was briefly announced by HHS secretary Alex Azar during a speech to the American Health
Drugs
New York University Tandon School of Engineering researchers say they have engineered nanoscale protein micelles capable of both delivering chemotherapeutic drugs and of being tracked by MRI imaging. A university news release says that as a “theranostic,” the innovation combines diagnostic capability and drug delivery, allow researchers to administer therapy
Devices
The National Evaluation System for health Technology (NEST) has test cases underway to demonstrate proof-of-concept for generating robust real-world evidence (RWE) in preparation for regulatory submissions such as label expansions or to meet postmarket surveillance requirements. Writing in a Clinical Pharmacology & Therapeutics commentary, CDRH director Jeffrey
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Mobilett Elara Max mobile X-ray system, which features improved information technology (IT) security as well as secure system integration into a hospital’s IT environment for immediate access to patient data. The system also has an improved design that
Drugs
FDA says that to assure patient access to the antihypertensive drug losartan, it will allow certain manufacturers to temporarily distribute losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the
Drugs
FDA has approved an Amphastar Pharmaceuticals ANDA for blood thinner enoxaparin sodium injection 300mg/3mL (100mg/mL) multiple dose vials, a generic copy of Sanofi-Aventis’ Lovenox. Amphastar also manufactures and distributes enoxaparin sodium injection in prefilled syringes. Enoxaparin sodium is used to treat and prevent deep vein thrombosis and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.” The document provides sponsors with nonclinical and clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products (including small
Drugs
People for the Ethical Treatment of Animals (PETA) says that following discussions with the advocacy group, Johnson & Johnson and its Janssen subsidiary have changed their policy and will no longer conduct or fund so-called forced swim tests in which mice, rats, and other small animals are placed in
Drugs
CDER senior science advisor for compounding Julie Dohm is leaving the agency to join Covington & Burling in its Washington, DC office, effective 3/29. As the top drug compounding official at the agency, Dohm led compounding activities involving multiple offices throughout the agency. She manages teams that implement legislation,