Drugs
A new CDER Office of Generic Drugs pilot program to offer meeting opportunities to ANDA applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) determinations is drawing skepticism from some food and drug lawyers. “The use of MIE approaches for BE establishment is increasingly prevalent, particularly
Drugs
FDA has approved a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis (UC). “Velsipity provides adults living with moderately to severely active UC the opportunity to achieve steroid-free remission with an oral, once-
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Quality Considerations for Topical Ophthalmic Drug Products.” The document discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. It addresses approaches to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Recall Regulations — 21 CFR Part 7.” The collection supports agency regulations and the practices and procedures related to product recalls. The regulations also cover corrective actions to be taken regarding violative products and establish specific guidelines
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Importation of Prescription Drugs.” The collection supports the implementation of Section 804 of the Federal Food, Drug, and Cosmetic Act and applicable regulations in 21 CFR part 251, which address importation of certain prescription drugs shipped from
Devices
FDA has cleared an InfoBionic 510(k) for its MoMe ARC, the company’s third-generation remote electrocardiogram monitoring device. The new device is paired with InfoBionic’s new Bluetooth diagnostic six-lead sensor that the company says is designed to help physicians diagnose arrhythmias in patients with a demonstrated
Devices
FDA has cleared a Heidelberg Engineering 510(k) for its ANTERION platform, which the company says is designed to transform anterior segment diagnostics and streamline eye care practice workflow. “As an all-in-one upgradeable platform, ANTERION combines biometry, IOL [intraocular lens] power calculation with corneal topography and tomography, anterior
FDA Policy/General
The CDER Office of Prescription Drug Promotion is planning to research how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers influence perceptions of a drug. A Federal Register notice says a related question is whether including a disclosure
Drugs
FDA has published a draft guidance, Quality Considerations for Topical Ophthalmic Drug Products, discussing quality considerations for ophthalmic drugs such as solutions, suspensions, emulsions, gels, ointments, and creams intended for topical delivery in and around the eye. The document specifically discusses: * approaches to evaluating visible particulate matter, extractables and leachables,
Biologics
FDA has issued Alvotech a complete response letter for its BLA for AVT04, a biosimilar of Janssen’s Stelara (ustekinumab). The letter cited “certain deficiencies” that were documented during an FDA March inspection of the company’s Reykjavik facility in Iceland, an Alvotech release says. “No other deficiencies in the
FDA Policy/General
Federal Register notice: FDA has determined that Novartis Pharmaceuticals’ Mekinist (trametinib dimethyl sulfoxide) tablets (1 mg) were not withdrawn for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Mekinist is a kinase inhibitor
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health (CDRH).” The collection describes such allegations as claims that a medical device manufacturer or individuals marketing medical devices or electronic products regulated by
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that an FDA draft guidance on QTc information in drug and biological product labeling does not fully embrace approaches discussed in a related International Council on Harmonization guideline. “We have concerns that the draft guidance effectively discourages the use
Biologics
Eli Lilly says it will seek FDA approval in 2024 for mirikizumab after reporting the drug met the co-primary and all major secondary endpoints compared to placebo in VIVID-1, a Phase 3 study in adults with moderately to severely active Crohn’s disease. In the study, a higher
Drugs
Rep. Abigail Spanberger (D-VA) and 14 other House Democrats are asking FDA and the Drug Enforcement Administration (DEA) for more information on their efforts to end the shortage of attention deficit hyperactivity disorder (ADHD) medications. In a statement (includes the text of the letter to the agencies), Spanberger and
Drugs
FDA has lifted a clinical hold against PepGen that will allow the company to begin the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in patients with myotonic dystrophy Type 1 in the U.S. The company says the condition (also known as Steinert’s disease) is a progressively disabling,
Biologics
FDA has granted MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastoma (nGBM). The designation was based on data from the company’s Phase 2a Study of SurVaxM for nGBM that found 51% of patients receiving SurVaxM survived at least two
Devices
FDA has created a new committee to advise the agency on issues related to digital health technologies (DHTs), providing relevant expertise and perspective to help improve FDA’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs. An online announcement says the Digital Health Technologies
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR Part 315.” The collection supports agency regulations in Part 315 where manufacturers of diagnostic radiopharmaceuticals are required to submit information (NDA/BLA) that demonstrates the safety
Biologics
A Tufts Medical Center for Biomedical System Design analysis finds that durable cell and gene therapy (CGT) programs for rare orphan conditions and CAR-T/TCR therapies for blood cancers have higher success once they enter the clinic compared to the combined pipeline of all therapies. A Center newsletter says
Devices
A 9/15 FDA update to its guidance on breakthrough medical devices says the agency may consider a device’s ability to improve health and healthcare disparities when deciding whether to award a breakthrough medical device designation. Writing in an online post, attorneys Thomas Greeson and Sung Park (Reed Smith)
Drugs
Sen. Richard Blumenthal (D-CT) is now urging FDA to investigate whether Philips Respironics criminally hid complaints about its faulty CPAP breathing devices over the course of 11 years before launching a massive recall in 2021. Last week, the senator asked the Department of Justice (DoJ) to investigate the company