Drugs
FDA says Teva has recalled one lot of IDArubicin hydrochloride injection 5 mg/5 mL vial based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. An agency notice says no other vials have been observed to contain the
FDA Policy/General
Federal Register notice: FDA is extending the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. Comments now can be submitted until 6/10. To view the notice, click here.
Drugs
FDA is recommending that newborns and children through age 3 have follow-up thyroid monitoring within three weeks after receiving injections of contrast media containing iodine for X-rays and other medical imaging procedures. A 3/30 Drug Safety Communication says the recommendation is based on the agency’s recent
Drugs
The Department of Justice says Robert Schneiderman, Langhorne, PA, pleaded guilty in New Jersey federal court to two counts of an indictment charging him with one count of conspiracy to commit healthcare fraud and one count of conspiracy to violate the Anti-Kickback Statute. A department statement says that from
Drugs
Medical Device User Fee Act (MDUFA) investments made since 2002 have “paid off dividends with an increasing number of device innovators bringing their devices to the U.S. first, and a more robust pipeline of innovative new devices, which ultimately has led to more timely patient access,” CDRH director Jeff
Devices
FDA has cleared a Sky Medical Technology 510(k) for its new (W3) geko device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency or ischemia. The (W3) device follows the company’s 2021 FDA-cleared (W2) geko device, which was also authorized for
Drugs
FDA says that sotrovimab is not authorized in HHS regions 5, 9, and 10 as of 3/30 because the Centers for Disease Control and Prevention says that the proportion of Covid-19 cases caused by the omicron BA.2 variant is above 50% in those regions. An agency statement
Drugs
FDA has issued a complete response letter for Akebia Therapeutics’ NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor under review for treating anemia due to chronic kidney disease. The company says FDA concluded the data in the NDA do not support a favorable benefit/risk assessment
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee delivered a near mixed vote 3/30 on whether Amylyx Pharmaceuticals’ experimental amyotrophic lateral sclerosis (ALS) therapy AMX0035 should be approved. Panel members voted 6 to 4 that data from the single randomized, controlled trial and the open-label extension
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). FDA’s regulations require that applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered
FDA Policy/General
More details are trickling out of FDA on the package of legislative proposals that were included in the Biden Administration’s fiscal year 2023 budget proposal for the agency 3/28 (see earlier story), including expanded authority to enhance remote regulatory assessments that were widely used during the Covid-19
Devices
The Department of Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) has issued a 3/29 medical advisory on the Philips e-Alert MRI system monitoring platform version 2.7 and prior. The advisory says the e-Alert is missing authentication for a critical function and successful exploitation of this
Drugs
FDA has just released the FDA-483s issued following 1/16-1/19/2017 and 8/7-8/11/2017 inspections at Zhejiang Hisun Pharmaceutical Co., a Taizhou City, Zhejiang, China, active pharmaceutical ingredient manufacturer. The form for the January inspection had these observations: * failing to follow quality control laboratory
Drugs
A 10/21-11/3/21 FDA inspection at the Agropharma Laboratories Salinas, Puerto Rico, drug manufacturing facility found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/25 Warning Letter says the specific violations were: * failure of the quality control unit to exercise its
Biologics
FDA has authorized a second booster dose of the Pfizer/BioNTech and Moderna Covid-19 vaccines for older people and certain immunocompromised individuals. The agency says the action will make a second booster shot available to other populations at higher risk for severe disease, hospitalization, and death. “Emerging evidence suggests
Drugs
An FDA records review determined that Dr Retter Ec Wladyslaw Retter, Mazowieckie, Poland, which is registered with FDA as a manufacturer of over-the-counter drug products, has significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/14 Warning Letter says specific violations are: * failing
Devices
AdvaMed says an FDA draft guidance on assessing the credibility of computational modeling and simulation in medical device submission “is an important step toward highlighting the importance of rules and physics-based modeling and simulation in the form of evidence in a regulatory submission.” The association’s comment letter says
Drugs
FDA has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for treating HIV-1 in virologically suppressed adolescents who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either
Devices
FDA has cleared a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate. The medical grade wearable monitors use proprietary non-invasive reflective photoplethysmography monitoring technology to automatically and continuously
Drugs
Several drug and medical device industry stakeholders have submitted comments on an FDA draft guidance on digital health technologies for remote data acquisition in clinical investigations. Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency’s ongoing efforts to facilitate the use of digital health technologies in
Devices
AdvaMed says it commends FDA efforts to develop a proposed transition plan for medical devices that fall within enforcement policies issued during the Covid-19 public health emergency. In its comment letter, AdvaMed says the agency draft guidance “is a crucial step to help avoid disruption in device supply. At
Drugs
FDA has approved a higher 2 mg dose of Novo Nordisk’s Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 analog indicated along with diet and exercise to improve blood sugar in adults with Type 2 diabetes and to reduce the risk of major cardiovascular events such as