Drugs
Reps. David McKiney (R-WV) and Abigail Spanberger (D-VA) have introduced the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE Act) to create an emergency supply of ingredients used in the manufacturing of vital generic medicines and to incentivize domestic manufacturing of these ingredients.
Drugs
Apellis Pharmaceuticals says it will file an NDA for pegcetacoplan, an investigational, targeted C3 therapy treating geographic atrophy (GA) secondary to age-related macular degeneration, in the first half of 2022 after announcing data from the Phase 3 DERBY and OAKS studies. GA is a leading cause of blindness that
Drugs
PharmaTher Holdings has retained former CDER Division of Psychiatry Products director Thomas Laughren, who retired in 2012, as a regulatory affairs advisor. The company says Laughren will advise on regulatory matters involving KetaBet, its patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for
Drugs
FDA has approved AbbVie’s Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The company says Qulipta is the only oral calcitonin gene-related peptide receptor antagonist specifically developed for this indication. AbbVie says the approval was supported by data from a clinical program evaluating the drug’
Biologics
While FDA has invested some resources in trying to regulate private clinics marketing stem cell products, “they’re just outmatched and overwhelmed,” according to University of California Irvine bioethicist Leigh Turner. Speaking to the Associated Press, Turner said the 2017 decision to give stem cell clinics three years to demonstrate
Drugs
FDA has published a guidance, Q3B(R2) Impurities in New Drug Products, with recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or International Conference on Harmonization (ICH) member state. The
Drugs
FDA has published a draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices, to help clinical investigators comply with safety reporting requirements for IND or IDE studies. The document has recommendations to help investigators identify (1) safety information for drugs that is considered an unanticipated problem involving risk
Drugs
FDA has published a draft guidance, Microbiological Quality Considerations in Non-Sterile Drug Manufacturing, to assist manufacturers in ensuring the control of the microbiological quality of their non-sterile drugs. The document’s recommendations apply to solid, semi-solid, and liquid non-sterile dosage forms. FDA says the non-sterile
FDA Policy/General
Federal Register notice: FDA has announced the fee rates for using a tropical disease priority review voucher for fiscal year 2022 — $1,266,651. The vouchers are awarded to the sponsors of certain tropical disease product applications submitted after 9/27/2007, upon approval. The notice also outlines the payment
FDA Policy/General
Federal Register notice: FDA has announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2022 — $1,266,651. The notice also outlines the payment procedures for such fees. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2022 — $1,266,651. The notice also outlines the payment procedures for such fees. To view the notice, click here.
Drugs
FDA has published a draft guidance, Benefit-Risk Assessment for New Drug and Biological Products, to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that FDA makes about NDAs and BLAs.
FDA Policy/General
Three former staffers in the FDA Office of Chief Counsel, who had been working for Hogan Lovells, have now joined Sidley’s Global Healthcare and FDA practice. Sidley says the three are former associate chief counsel for enforcement Jim Johnson, former associate chief counsel for enforcement Scott Kaplan, and former
Drugs
Researchers from the University of Chicago Booth School of Business say if FDA were to use a more data-driven approach in its postmarket drug analysis, there would be fewer cases in which safe drugs are wrongly penalized. To make their point, the researchers used different data to reanalyze the
Devices
FDA has cleared NeuroWave Systems’ NeuroSENSE NS-901 monitor, a new generation brain function monitor that assesses the adequacy of anesthesia and sedation in clinical settings. The company says NeuroSENSE is a unique bilateral brain function monitor for anesthesia specialists that simultaneously provides independent indices of anesthesia effect for each
Devices
FDA has issued a warning about the potential risk of injury associated with the use of Max-Lux Corp.’s Safe-T-Lite UV Wand because users and those nearby may be exposed to unsafe levels of ultraviolet-C radiation that may cause injury to the skin, eyes, or both
Drugs
FDA has approved Mirum Pharmaceuticals’ Livmarli (maralixibat) oral solution to treat cholestatic pruritus in patients with Alagille syndrome age one and older. Mirum says Livmarli is a minimally absorbed ileal bile acid transporter inhibitor. It is the only FDA-approved medication for this rare liver disease. As part of the
Devices
Magellan Diagnostics has recalled its LeadCare II, LeadCare Plus, and LeadCare Ultra blood lead tests due to concerns about false low results. The agency says a false low result may lead to health risks in special populations such as young children and pregnant individuals. “A pregnant or lactating individual'
Drugs
A panel of FDA staff from CDER and the Office of Regulatory Affairs provided the latest insight into common data integrity inspection findings during a 9/28 session at the annual FDA/Parenteral Drug Association regulatory conference. One common issue is firms’ review of electronic data, such as electronic chromatograms,
Biologics
In the wake of two senior FDA vaccine officials leaving the agency (see earlier story) during the next month, CBER director Peter Marks has announced he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director. Marks is replacing OVRR director Marion Gruber, who is retiring 10/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment. The document addresses FDA’s current thinking on clinical trial design issues, choice of study population, and endpoints for the treatment of naïve and refractory nontuberculous
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions. The document is part of FDA’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in