Drugs
Greenleaf Health says it has added good clinical practice services to its range of FDA regulatory consulting efforts. The company says its expanded good clinical practice services build on its robust compliance portfolio by working with life science entities to evaluate and strengthen clinical quality systems. The company says its
Drugs
FDA has granted Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test. The designation was based on data from multicenter prospective clinical trials that suggest that the non-invasive, blood-based IsoPSA assay has superior diagnostic accuracy when compared to traditional prostate-specific antigen
FDA Policy/General
Federal Register notice: FDA is requesting nominations for a nonvoting representative to serve on the Tobacco Products Scientific Advisory Committee. In addition, it is requesting that any industry organizations interested in participating in the selection of a nonvoting representative notify the agency in writing. To view the notice, click here.
Drugs
FDA acting commissioner Ned Sharpless says the agency approved a total of 1,171 generic drugs (935 full approvals and 236 tentative approvals) in FY 2019, setting a record. In a statement, Sharpless says the approvals beat the FY 2018 record of 971 total approvals. He also said that in
Drugs
Washington Legal Foundation (WLF) says an FDA proposed rule to require photorealistic color graphics to accompany textual warnings on cigarette packs violates the First Amendment. In comments to the agency, WLF challenges the FDA claim that because a significant information gap exists, the proposed rule is necessary to inform the
Drugs
FDA has issued a guidance, Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products, with recommendations to applicants about requests for waivers, refunds, and reductions of user fees for drugs and biological products. The document revises a 9/2011 guidance. The agency says the revised
Drugs
Public Citizen says that amendments announced 10/16 to H.R. 3, the Lower Drug Costs Now Act, contain several “modest improvements,” but more still needs to be done. In a statement, Public Citizen says the amendments include allowing the government to negotiate prices for some newly launched drugs, eventually
Drugs
Eli Lilly says top-line results from the Phase 3 SEQUOIA trial evaluating its pegilodecakin plus Folfox (folinic acid, 5-FU, oxaliplatin) show that pegilodecakin failed to meet its primary endpoint of overall survival in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line
Devices
HHS’s Office of Inspector General (OIG)says it is assessing FDA’s medical device postmarket surveillance activities. “As the information that the FDA receives about medical device safety and effectiveness is increasingly gathered in the postmarket setting, it is more important than ever that FDA’s postmarket safety surveillance
Drugs
ViiV Healthcare has filed a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure. Dovato is currently approved as a complete, once-daily, single-tablet regimen for HIV-1 in adults
Devices
A 10/2 CDRH Webinar offered recommendations for improving dental device 510(k) submissions. Office of Health Technology One acting assistant director Michael Adjodha said the “refuse-to-accept” rate for dental devices in the first round of review is above 80% and involves several issues that were discussed in
Drugs
FDA has approved a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults and children six months of age and older. Approval was based on data from a trial involving 262 patients aged 18 years of age and older who presented to an emergency department
Drugs
FDA has issued a safety alert on Efficient Laboratories’ Rompe Pecho EX and Rompe Pecho CF cough syrups due to microbial contamination risks. The agency recommends that the over-the-counter medicines not be used because they could cause illness. The alert says that the agency 10/9 urged the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Potential Tobacco Product Violations Reporting Form” (OMB Control Number 0910-0716). The form is related to the agency’s authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and
Drugs
FDA drug reviewers appear to be focused on mortality concerns with a Shionogi NDA for cefiderocol injection that heads to an advisory committee vote 10/16 for its proposed indication to treat complicated urinary tract infections (cUTI). According to just-posted briefing materials, the agency aims to have a discussion
Devices
FDA has cleared a Subtle Medical 510(k) to market SubtleMR, an artificial intelligence image processing software that uses “denoising and resolution enhancement” to improve image quality, according to the company. It uses “proprietary deep learning algorithms” to improve technology with existing scanners, it says. The software improves the quality
Drugs
FDA has approved a Noven Pharmaceuticals NDA for Secuado (asenapine) transdermal system for treating adults with schizophrenia. Approval is based on data from a Phase 3 placebo-controlled study in which Secuado achieved the primary endpoint of statistically significant improvement from baseline compared to placebo at week six, according to
Drugs
With Canada and the European Union releasing much of the data companies submit when seeking approval for a new drug, biologic, or medical device, pressure is being placed on FDA to change its stance that says that such information contains confidential trade secrets and can’t be released. National Public
Drugs
A 4/8-4/16 FDA inspection at Torrent Pharmaceuticals, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/8 Warning Letter says specific violations were: * failing to follow written procedures for production and process control designed to assure that the drug
Drugs
A 4/15-4/20 FDA inspection at Glenmark Pharmaceuticals, Mumbai, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/3 Warning Letter says the specific violation was failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
The Association for Accessible Medicines suggests that FDA include additional details concerning expected justification content when referencing an Inactive Ingredient Database (IID) listing that differs from the proposed excipient in nomenclature, molecular weight, viscosity, or grade. The group made the suggestion in its comment to an FDA draft guidance on
Devices
FDA has made available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for device companies to use when communicating any cybersecurity concerns to patients. Panel members recommended that the format for cybersecurity messages to patients should include e-mails, Web postings, social