Drugs
CDER Office of Quality Surveillance director Jennifer Maguire says FDA samples drugs for general quality surveillance and for targeted investigations in response to information about suspected quality issues with drugs on the market. In an online interview post, Maguire says the information analyzed through the drug quality sampling and testing
Drugs
FDA has told Soleno Therapeutics that a proposed change to the company’s study of DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome might address the agency’s concerns about the adequacy of the overall efficacy data supporting an NDA. Soleno says the study protocol has been
Drugs
FDA has published a draft guidance, Human Prescription Drug and Biological Products—Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers—“Dose Banding”, with recommendations to assist applicants in incorporating information into proposed human prescription drug labeling under specified conditions. The document applies to
Devices
FDA has issued a safety warning about the use of certain brands of ultraviolet (UV) wands because the devices may expose users and any nearby people to unsafe levels of ultraviolet-C radiation. The warning says that such exposure may cause injury to the skin and eyes after a few
FDA Policy/General
The Veeva Field Trends 2022 report says that in-person now accounts for about 70% of interactions between drug company field staff and healthcare providers. “Although in-person is again the predominant channel,” the Veeva report says, “now that 75% of healthcare providers expect a blend of digital engagement, field
Devices
FDA has cleared a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation system, for treating anxiety symptoms for adult patients who suffer from major depressive disorder, also known as anxious depression. The company says the clearance relied on
Drugs
A 1/31-2/4 FDA inspection at the Bioiberica, SAU, drug manufacturing facility in Barcelona, Spain, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 6/30 Warning Letter says specific deviations were: * failing to establish written procedures to monitor the progress
Drugs
FDA says a review of promotional materials in ophthalmology professional journals for Imprimis Rx’s compounded Pred-Moxi-Brom (prednisolone acetate 1%, moxifloxacin 0.5%, and bromfenac 0.075%) found that they make false or misleading claims about the drug and thus misbrand the drug product. A 6/30 Warning
Drugs
FDA has lifted a clinical hold against Viking Therapeutics’ VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD), and the company says it will resume study enrollment in the coming weeks. The agency action followed its review of results from an in vivo genotoxicity study that it had requested due
Drugs
Merck says it is stopping for futility its Phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without bevacizumab for treating patients with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The stoppage was recommended by an independent data monitoring committee after they reviewed
Drugs
CDER director Patrizia Cavazzoni has appointed associate director for controlled substances Marta Sokolowska to serve as deputy Center director for substance use and behavioral health, a new position in the Center. In this new role, she will continue to oversee the Controlled Substances Program at the agency. “At a time
Drugs
The Washington Legal Foundation (WLF) says a 7/29 HHS Office of Inspector General (OIG) advisory opinion rejecting a proposal to permit pharmaceutical and medical device industry sponsorship of a continuing education program for healthcare providers “could have significant implications for how life sciences companies contribute towards continuing education programs
Drugs
Santa Monica, CA, pain specialist Gerald Sacks has agreed to pay $271,259.12 to resolve allegations that he violated the False Claims Act in connection with prescribing Purdue Pharma and Depomed medications to Medicare beneficiaries. A Department of Justice release says Sacks prescribed the medications in exchange, at least
Devices
FDA has granted breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing for the disease. The company says it is the first in-vitro diagnostics manufacturer to receive this designation
Drugs
FDA has accepted for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The agency set a user fee review action target date of 11/26. GA is an advanced form of AMD
Drugs
The Alliance for Natural Health, saying it is acting on behalf of its one million consumer supporters, is calling on FDA to require manufacturers of proton pump inhibitors (PPIs) to add a Boxed Warning to the product labeling describing the link between taking PPIs and the risk of developing dementia.
Devices
FDA has added two updates to its Supplies of Medical Devices for Covid-19 Frequently Asked Questions Web page. The first update adds information about how the agency determines it is appropriate to remove a product code from the device shortage list, and the second tells what FDA is doing
Devices
FDA has granted de novo marketing authorizations for Apollo Endosurgery and its Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx systems for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision. The devices are intended to be used in adults with obesity with a body mass index between
Biologics
The U.S. CDC Advisory Committee on Immunization Practices 7/19 voted unanimously to recommend the use of the Novavax Covid-19 Vaccine, Adjuvanted as a two-dose primary series in individuals aged 18 and older. This follows last week’s FDA emergency use authorization (see earlier story). The company
Devices
CDRH is seeking feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions. Effective 7/18, existing users of the Center’s Customer Collaboration Portal’s progress tracker will be able to try out the process and provide user feedback on the
FDA Policy/General
Federal Register notice: FDA is making available draft guidance #100 entitled “Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2).” The document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the target animal and for residues in products derived from treated
Drugs
Sanofi has told Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating Alport syndrome after data failed to meet Sanofi’s pre-defined futility criteria. Previously, Sanofi acquired from Regulus the rights for developing and marketing RG-012. Regulus says