Drugs
FDA has approved the use of GlaxoSmithKline’s Benlysta (belimumab) intravenous (IV), a B-lymphocyte stimulator-specific inhibitor, in children aged five years and older with lupus. This is the first time that FDA has approved a treatment for pediatric patients with systemic lupus erythematosus (SLE), a serious chronic disease
Drugs
Writing in the Journal of the American Medical Association, former FDA commissioner Robert Califf and former Centers for Medicare and Medicaid Services acting administrator Andrew Slavitt say the “most promising path toward a fair system” of prescription drug pricing is what they term value-based payments. They write that “encouraging
Drugs
FDA has chosen Pew Charitable Trusts drug regulatory policy expert Elizabeth Jungman as Office of Regulatory Policy director, effective in July. At Pew since 2014, Jungman oversees initiatives related to antibiotic innovation, prescription drug safety, over-the-counter medicines, and other consumer health care products. Before joining Pew, she was
Devices
FDA has issued a guidance, Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, to be used by members of industry who submit applications for orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) material. The document is intended to assist sponsors in determining the appropriate information and testing
Devices
FDA is reminding healthcare professionals and patients to carefully follow labeling and instructions for use for the Stryker Wingspan stent system and to consider the specific patient selection criteria for the device so they can appropriately determine whether the device is right for them. An agency safety communication says Wingspan
Devices
FDA has approved a Boston Scientific PMA for the LOTUS Edge Aortic Valve System. Delivered during a minimally-invasive procedure, the company says the transcatheter aortic valve replacement technology is indicated for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart
FDA Policy/General
The National Institutes of Health (NIH) has released its amended NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, that remove the requirement to register and report on human gene therapy protocols under the NIH Guidelines to the NIH. The amended guidelines stem from an 8/2018 joint
Devices
FDA has published a guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission such as
Devices
FDA has released a final guidance on “Unique Device Identification: Convenience Kits.” The document discusses an agency exception for complying with unique device identification (UDI) system regulations that require that the label and device package of a device must bear a UDI. The exception is provided for devices packaged within
Drugs
Gilead Sciences says its Phase 3 STELLAR-3 study, which evaluated selonsertib in patients with bridging fibrosis due to nonalcoholic steatohepatitis (NASH), missed the primary endpoint. Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis and fibrosis in settings of oxidative stress, according to
Drugs
FDA has approved an Ortho Dermatologics NDA for Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults. The company says that when used separately to treat psoriasis, halobetasol propionate’s (a corticosteroid) use duration is limited by FDA labeling
Drugs
The Department of Justice says Astellas Pharma and Amgen have agreed to pay $124.75 million to resolve allegations they each violated the False Claims Act by illegally paying Medicare copays for their own products through purportedly independent foundations that the firms used as conduits. The government says the Astellas
Drugs
Eli Lilly is withdrawing Lartruvo (olaratumab) from the market based on data from a confirmatory trial in which the drug did not improve survival for patients. Results from ANNOUNCE, a Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did
Devices
Two former Arriva Medical executives will each pay $500,000 to settle False Claims Act charges that they caused the company to submit false claims to Medicare that were tainted by kickbacks paid to beneficiaries in the form of free or no-cost home blood glucose meters or waived or
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” The document says that the target population for a new drug or biologic usually includes individuals with diverse prognostic factors, and the population studied in
Drugs
Federal Register notice: FDA has made available a final guidance entitled “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.” The document was prepared in response to requests from states asking the agency what would be necessary to provide confidence that stockpiled doxycycline has retained its original quality
Drugs
FDA has published a guidance, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, to help government public health and emergency response stakeholders determine if stockpiled doxycycline tablets and capsules have retained their purity and potency beyond the manufacturer’s labeled expiration date so the replacement of stockpiled
Drugs
FDA has published a draft guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes, to give the agency’s recommendations for adjusting for covariates in randomized clinical trials with continuous endpoints that are appropriate for analysis with normal-theory methods, such as the two-
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and
FDA Policy/General
Federal Register notice: FDA has announced a 5/30-31 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting. On 5/30, panel members will discuss and make recommendations on a reclassification proposal for surgical stapler devices for internal use from Class 1 (general controls) to
FDA Policy/General
Federal Register notice: FDA has made available an update to the immediately in effect guidance entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” The document describes FDA’s compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety
Devices
FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon (SEB) for treating coronary in-stent restenosis (ISR). “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential