Drugs
FDA has denied a 10/3/2017 petition submitted by Axinn, Veltrop & Harkrider requesting permission to submit an ANDA for apixaban tablets 10 mg, with a reference-listed drug of Bristol-Myers Squibb’s Eliquis in 2.5 mg and 5 mg doses. The denial letter says the proposed
Drugs
FDA has released a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals’ Windsor, CT outsourcing facility that cited significant GMP deficiencies. For example, the agency took issue with the firm’s lack of quality control efforts because it does not require identification of particulates
FDA Policy/General
Federal Register notices: FDA has published eight notices about the regulatory review period determinations for the following drug products: * KemPharm’s Azstarys (serdexmethylphenidate and dexmethylphenidate), indicated for treating attention deficit hyperactivity disorder in patients six years of age and older. The regulatory review period is 1,676 days, of which
Drugs
FDA has accepted for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults. The agency has set a 9/26/2024 review action target date. Karuna says the submission is based on data from the company’s EMERGENT clinical trial program. “In all three placebo-
Drugs
The American Society of Hematology says it commends FDA for releasing its draft guidance on developing products to prevent or treat graft-versus-host disease (GVHD). The society comment letter says investigators and hematologists conducting stem cell transplants can benefit from the guidance on acute and chronic GVHD. “To ensure
Drugs
CDER researchers simulating how factors may affect corticosteroid nasal deposition say that on average, more than 94% of the medication went into the nasal cavity. “At least 91% of all drug mass entered the nose,” an online post says. “Overall, the different sprays had little effect on medication distribution.” The
Devices
FDA has cleared a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating adults with severe obstructive sleep apnea (OSA). The clearance was based on “statistically significant data” from 73 severe OSA patients that showed 80% of patients experienced an improvement of
Devices
FDA says it is still evaluating information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. In 2021, the agency issued a notice saying that a real-world data analysis “indicates that procedural outcomes such as major
Drugs
Several Skadden attorneys say an increased focus on cybersecurity could pose False Claims Act (FCA) exposure risk for life sciences companies. Writing in a lengthy online newsletter, the attorneys review FDA’s promotional enforcement update, Warning Letters arising out of inspection activities, and a loss on statutory interpretation. The report
Biologics
FDA has published a guidance, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, describing a CBER program to identify and recognize voluntary consensus standards (VCS) to facilitate the development and assessment of regenerative medicine therapy products when such standards are appropriate. The document says CBER encourages the use of
Drugs
A 5/1-5/12 FDA inspection at the Intas Pharmaceuticals drug manufacturing facility in Matoda-Sanand, Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, many of which were similar to those from an earlier inspection. An 11/21 Warning Letter says specific
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Cara Therapeutics’ Korsuva (difelikefalin acetate), indicated for treating moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The regulatory review period is 4,625 days, of which 4,381 days occurred
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for G1 Therapeutics’ Cosela (trilaciclib), indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topetecan-containing regimen for extensive-stage small cell lung
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Shortages Data Collections.” The collection supports agency regulations giving CDRH authority to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand
Drugs
FDA is warning of a rare but serious drug reaction to two anti-seizure medications — levetiracetam (UCB’s Keppra and Keppra XR, TriPoint Therapeutics’ Elepsia XR, and Aprecia Pharmaceuticals’ Spritam) and clobazam (Lundbeck Pharmaceuticals’ Onfi and Otter Pharmaceuticals’ Sympazan). An agency drug safety communication says the reaction is called Drug
Drugs
Acelyrin says it is contracting with an independent auditor to review trials of izokibep being conducted by a contract research organization for the company, including a psoriatic arthritis trial and a moderate-to-severe hidradenitis suppurativa trial. The planned audit follows reports of clinical trial execution errors by the research
Drugs
FDA says its review of a Web site maintained by Dr. Berne’s Whole Health Products in Tesuque, NM, determined that the site offers three illegal eye drop products for sale in the U.S. An 11/22 Warning Letter says the products are unapproved new drugs and are adulterated.
Devices
FDA says it is investigating an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies, and is evaluating the need for regulatory action. The agency says it has received reports of T-cell malignancies, including CAR-positive lymphoma, in
Devices
FDA has issued a warning on Philips’ DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat. The agency says patients and healthcare providers should carefully monitor the devices for signs of overheating based on medical device reports (MDRs) it has received recently about thermal issues such
Drugs
President Biden has announced that his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to mitigate drug shortages. A Presidential Determination is planned to be issued to give HHS broader authority to “enable investment in domestic manufacturing of essential medicines, medical countermeasures, and
Drugs
FDA and the Duke-Margolis Center for Health Policy are holding a hybrid (online/in-person) public meeting 1/31 on “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.” The meeting is intended to discuss with stakeholders
Drugs
Researchers say a pilot program using a mixed reality device with a collaborative text messaging system allowed multiple national regulatory authorities, including FDA, to perform a regulatory inspection of a good manufacturing practice (GMP) facility simultaneously, while still following their respective internal procedures. Writing in Therapeutic Innovation & Regulatory Science,