Drugs
Responding to a comment submitted by former FDA Office of Orphan Product Development director Timothy Cote on a Sidley 11/2/2023 petition submitted on behalf of a client involving orphan drug exclusivity (ODE) for an investigational oral vigabatrin solution, Sidley says Cote’s arguments “are frivolous and should be
Drugs
FDA has approved a new indication for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults for Vanda Pharmaceuticals’ Fanapt (iloperidone). A company statement says Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since
Drugs
Bipartisan legislation has been introduced in the House of Representatives to help “address drug-gene interactions” and to ensure that Americans have access to treatment personalized to their needs. Introduced by Representatives Eric Swalwell (D-CA) and Dan Crenshaw (R-TX), the Right Drug Dose Now Act will “enable the
Drugs
FDA has issued Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspected 10/2023. FDA investigators cited the firm for failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, the agency said Contract Pharma
Drugs
An HHS white paper on “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States” discusses some of the roles that FDA plays and wants to play in responding to drug shortages. The paper says the agency’s response focuses on the intake of information
Drugs
FDA has approved Basilea Pharmaceutica International’s Zevtera (ceftobiprole medocaril sodium for injection) to treat adults with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adult and pediatric patients three months to less than 18 years old
Drugs
Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for treating presbyopia, which affects near vision in people over 45. The data from CLARITY 1 and 2 trials showed that LNZ100 (1.75% aceclidine) achieved the primary
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) annual report for 2023 says it supported 55 novel drug approvals, including 17 biotechnology products. The report also credits OPQ with 359 expedited quality assessments to address drug shortages, 28 priority assessments to address orphan diseases, and 65 pre-license inspections in 10
Drugs
AdvaMed says it appreciates that FDA issued a revised draft guidance on questions and answers about conducting remote regulatory assessments (RRA) and continues to support the concept of RRAs. In its comment letter, AdvaMed says it is “important that RRAs be implemented in a manner that both serves FDA’s
Drugs
An 11/6-11/10/2023 FDA inspection at the Betone SA de CV drug manufacturing facility in Zapopan, Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/21 Warning Letter says specific violations were: * failure to have, for each batch of
Drugs
FDA has posted its report on potential signals of serious risks/new safety information identified by the Adverse Event Reporting System in the fourth quarter of 2023. The post contains 20 signals. FDA says it approved labeling changes for five of the items and is evaluating the need for regulatory
Drugs
Rep. David Schweikert (R-AZ) has introduced the Substance Therapy Designation Act that he says would allow for opioid, cocaine, methamphetamine, and alcohol treatments to be eligible for an FDA breakthrough designation. “The designation significantly expedites the development and review of such treatments,” he says in a statement (includes a
Drugs
FDA has released a draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” that provides recommendations to applicants and testing site management on maintaining data integrity for drug-related clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted to CDER. The recommendations in the
Drugs
Eli Lilly, which recently obtained FDA approval for its Zepbound (tirzepatide) as a weight-loss drug, says that as the agency revises its 2007 guidance on developing products for weight management it should clearly state that obesity is a complex, chronic disease. In a comment letter, Lilly says such a
Drugs
FDA has released a guidance entitled “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products.” The document is intended to assist submitters in transmitting electronic individual case safety reports (ICSRs) and attachments to the FDA Adverse Event Reporting System (FAERS)
Drugs
FDA says it is developing new processes to help identify drug postmarket safety issues. For example, the agency’s Sentinel Initiative is using the FDA Sentinel Innovation Center (IC), to test “machine learning and natural language processing technologies to more effectively access and integrate data in clinical narratives for safety
Drugs
FDA has approved AstraZeneca’s Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating extravascular hemolysis (EVH) ) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Danicopan is described as a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-
Drugs
FDA has released a final guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” The document provides instructions for electronically submitting to FDA’s Adverse Event Reporting System (FAERS) expedited individual case safety reports (ICSRs) from IND-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA’s recent draft guidance titled “Potency Assurance for Cellular and Gene Therapy Products” needs additional specificity and considerations for particular development phases. “Accordingly, PhRMA recommends including additional detail regarding phase-appropriate implementation and how the guidance would be applied to different
Drugs
FDA has cleared an Otsuka Pharmaceutical and Click Therapeutics 510(k) for Rejoyn, a prescription digital therapeutic authorized for treating major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms.
Drugs
FDA says its electronic Submission Template And Resource (eSTAR) system is now available for voluntary 513(g) requests for information sent to CDRH. 513(g) requests for information involve the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,
Drugs
FDA has lifted a partial clinical hold against ProJenX and its Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin — a first-in-class MAP4 kinase (MAP4K) inhibitor—in healthy volunteers and participants with amyotrophic lateral sclerosis (ALS). “The healthy volunteer portions of the trial have been completed,