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
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Glenmark Pharmaceuticals, Mumbai, India (10/3): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, Glenmark failed to thoroughly investigate multiple complaints
Drugs
FDA has approved an Akorn ANDA for betamethasone dipropionate lotion USP (augmented), 0.05%, a corticosteroid indicated for relieving inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. Sales of the generic lotion are estimated at $10 million annually. The product will be
Devices
A 5/1-5/6 FDA inspection at Denterprise International, Ormond Beach, FL, found Quality System Regulation and other violations in the firm’s work as specification developer, manufacturer of the FlashRay dental X-ray sensor and the MobileX, Model T-100, dental X-ray system. A 10/9 Warning
Drugs
FDA says it does not have scientific evidence to recommend whether individuals should continue or stop taking ranitidine (Zantac) medicines at this time. “The agency is conducting further tests to determine the risk to consumers” of the presence of NDMA (N-nitrosodimethylamine) impurities in ranitidine products, an online question-and-
Drugs
Of 59 new molecular entities approved by FDA in 2018, 48 included a table summarizing whether patient experience data (PED) was used during the agency drug review. Some 71% of the 48 approvals reported using PED in the review, with patient-reported outcomes the most significant source of PED. Sanofi
Drugs
FDA has extended the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension) that seeks to revise the drug’s label based on results from an open-label Phase 3b clinical trial which evaluated repeat administration of Zilretta in patients with osteoarthritis knee pain.
Drugs
A new JAMA study shows minimal effects from FDA’s recent policies to expand approvals for generic drugs at risk for price spikes and shortages. “From July 2016 to December 2018, the total number of generic drug applications approved by the FDA increased slightly, but the proportion of approvals for
Drugs
FDA has denied a 2006 citizen petition from UCB that sought labeling on all anti-epileptic drugs indicating that “physicians and pharmacists should exercise extreme caution when switching patients who are seizure free or whose seizures are well controlled on a given anti-epileptic drug.” In stating the basis for