Drugs
FDA is asking for comments on factors that should be considered when reviewing modification requests from sponsors of drugs subject to risk evaluation and mitigation strategies (REMS) related to changes in third-party vendors engaged by sponsors to help implement and manage the strategies. A Federal Register notice says that
Drugs
The International Council for Harmonization (ICH) has released for public comment a draft guideline entitled “ICH Harmonized Guideline — Good Clinical Practice (GCP) E6(R3).” The document is intended to provide a unified standard to facilitate mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory
Drugs
FDA is soliciting proposals for effective artificial intelligence systems that can assist it with imaging technologies for drug products. The solicitation says potential contractors are asked to submit proposals for non-invasive, high-resolution imaging technologies with artificial intelligence-powered analytics to measure drug performance and develop deeper analyses. Some
Drugs
The Digital Medicine Society (DiMe), dedicated to advancing digital medicine to optimize human health, says it applauds FDA’s commitment to addressing using digital health technologies in drug and biological drug development. Responding to an agency 3/2023 Framework for the Use of Digital Health Technologies in Drug and Biological
Drugs
FDA says it has determined that Champaklal Maganlal Homeo Pharmacy Private Limited in Gujarat, India, is manufacturing, importing, or distributing two unapproved drugs through CAD Import and Pharmadel, both in New Castle, DE. A 5/18 Warning Letter says the firm’s Bebelyn Diarrhea and Bebelyn Colic are particularly concerning
Drugs
University of Florida law professor Lars Noah wants FDA to take administrative action to define when client-seeking ads by personal injury lawyers related to FDA-regulated therapeutic products would qualify as potentially misleading lawyer advertising related to drugs and devices. In a 5/19 petition, Noah attaches an article
Drugs
FDA has issued a safety alert on over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR LLC, because they may contain the incorrect product and cause patient harm. “Novis received multiple complaints from pharmacies that found the wrong product – Finafta
Drugs
Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should address the use of external controls and real-world data/evidence (RWD/E) in the context of accelerated approvals, and harmonize its draft guidance on “Clinical Trial Considerations to Support Accelerated Approval
Drugs
The DC District Court has temporarily granted an attorney’s motion to keep his identity secret (see earlier story) in connection with a form FDA-483 that was scheduled to be published. The suit, which lists J. Doe as the attorney, says the agency intended to publish the FDA-483
Drugs
FDA has approved a Braeburn Inc. NDA for Brixadi (buprenorphine) extended-release injection (subcutaneous) for treating moderate to severe opioid use disorder. Brixadi comes in two formulations — a weekly injection for patients who have just started treatment, and a monthly version for patients already being treated with buprenorphine. An FDA
Drugs
Rep. Chip Roy (R-TX) has reintroduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act that would expedite FDA’s approval process for potentially lifesaving medicines by allowing “reciprocal approval” of drugs approved in other trusted nations. “The American people should not have to wait years and
Drugs
FDA has approved an Entasis Therapeutics NDA for Xacduro (sulbactam and durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Sulbactam is structurally related to penicillin and durlobactam protects sulbactam from being degraded by
Drugs
FDA has denied a 6/2020 Alliance for Natural Health citizen petition that urged the agency to require all makers of proton pump inhibitors (PPIs) to expand the existing label Warnings to include information about an increased risk of pneumonia. The group’s petition said “the causes of PPI-associated
Drugs
FDA has issued Camden, NJ-based contract testing laboratory Sure-Biochem Laboratories a just-posted Warning Letter after a 10/2022 inspection cited significant GMP violations associated with the firm’s microbial testing of finished drug products. For example, the agency letter says the testing lab “failed to follow required
Drugs
Despite testimony from three already convicted cooperating witnesses, a Miami federal jury 5/18 acquitted Tellus Clinical Research CEO Fidalgis Font and clinical study coordinator Julio Lopez in their alleged role of falsifying research data. Jurors also acquitted physician Martin Valdes of conspiracy, fraud and money laundering charges, but they
Drugs
FDA has agreed to a PolyPid Ltd. Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal colorectal surgical site infections (SSIs). The revised trial will recruit patients undergoing colorectal resection surgery with large incisions (greater than 20 cm), according to the company. Recruitment into
Drugs
FDA has denied a Public Citizen petition urging the agency to require a Boxed Warning for all sodium-glucose cotransporter-2 (SGLT-2) inhibitor drugs contraindicating their use in patients with Type 1 diabetes. “There is irrefutable evidence from multiple randomized clinical trials that the SGLT-2 inhibitors canagliflozin (Janssen’
Drugs
FDA has approved a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis (ISM). The rare hematologic disorder can lead to several debilitating symptoms across multiple organ systems, according to the company. The drug was designed to potently and selectively inhibit KIT D816V, the primary underlying
Drugs
Novo Nordisk says it will seek FDA approval for obesity drug semaglutide 50 mg tablets after announcing that the Phase 3a OASIS 1 trial met its primary endpoint — demonstrating a statistically significant and superior weight loss at week 68 versus placebo. Injectabe semaglutide (Wegovy) was approved in 2021 for treating
Drugs
Rain Oncology says it will not pursue further development of milademetan in dedifferentiated liposarcoma after reporting disappointing topline data from its pivotal Phase 3 MANTRA trial. The trial did not meet its primary endpoint of progression free survival (PFS). In the study, the median PFS for milademetan was 3.6
Drugs
FDA has approved an Opiant Pharmaceuticals NDA for Opvee (nalmefene HCl) nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. “On the heels of the FDA’s recent approval of the first over-the-counter opioid
Drugs
FDA 5/19 issued Aurobindo Pharma a four-observation Form FDA-483 after concluding a five-day inspection of the firm’s Unit XIV active pharmaceutical ingredient (non-antibiotic) manufacturing facility at Paravada Industrial Area in Andhra Pradesh, India. “The observations are procedural in nature,” the company says, adding that