Drugs
Researchers from several organizations and institutions say the use of extrapolation from adult to pediatric drugs between 1/1/2015 and 7/31/2021 increased the rates of new and expanded indications in the period. Writing in the Journal of Biopharmaceutical Statistics (purchase required), the researchers say that within the
Biologics
CBER Office of Tissues and Advanced Therapies director Wilson Bryan, who has announced his retirement from the agency, is concerned about accelerated approvals for cell and gene therapies considering how long it can take to complete confirmatory trials, according to a Bloomberg Law report. Speaking 2/13 at the Biopharma
Devices
FDA has cleared a 510(k) submitted by Belgium-based Sunrise for its second generation at-home sleep apnea test that uses artificial intelligence (AI) to aid in diagnosing obstructive sleep apnea and sleep-related breathing disorders. The device is intended to measure sleep through the bio-signal of mandibular
Drugs
With FDA remaining silent on orphan drug exclusivities for products approved after the 2021 11th Circuit Court of Appeals decision in Catalyst Pharmaceuticals v. Becerra, there is a backlog of exclusivity decisions awaiting FDA action. That’s the report of attorneys Jacqueline Berman and Nikita Bhojani (Morgan Lewis) writing in
Devices
AdvaMed says it appreciates that FDA has issued a draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, to update a previous guidance to include medical devices. The association’s statement says FDA should: * highlight throughout the document that an establishment may provide a
Drugs
A joint FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting unanimously voted 2/15 to recommend the nonprescription use of Emergent BioSolutions’ Narcan (naloxone HCl) nasal spray, 4 mg/.1 mL, for treating known or suspected opioid overdose. The 19-0 vote came
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device Labeling Requirements; Unique Device Identification (UDI).” The agency says that for operational efficiency it is revising the collection to include burden that may be attributable to activities associated with provisions found in part 830 (21
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.” The document provides a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a safety determination
Drugs
FDA has issued Soligenix a refuse-to-file letter for its HyBryte (synthetic hypericin) NDA that is seeking an indication for treating early stage cutaneous T-cell lymphoma. The letter says the NDA, which was submitted 12/14/2022, was not sufficiently complete to allow the review. The company says
Drugs
A 9/12-9/16/22 FDA inspection at the Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil drug manufacturing facility in Tuzia/Istanbul, Turkey, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/13 Warning Letter says the specific violations were: * failing to test
Devices
A 6/22-7/6/22 FDA inspection at Wintech Medipro in Katy, TX, found multiple violations in the firm’s manufacturing of surgical masks for which it does not have an approved PMA or IDE in place. A just-released 11/16/22 Warning Letter says the masks have
Drugs
Six Republican senators and five GOP House members have written to FDA commissioner Robert Califf, HHS secretary Xavier Becerra, and National Institutes of Health (NIH) acting director Lawrence Tabak raising questions about a “revolving door” between FDA and major drug companies. The letter is based on a Project Veritas interview
Drugs
FDA says staff from CDER and CBER will be part of a new International Council on Harmonization (ICH) formal expert working group to develop the guideline (ICH M15), which will outline principles for Model-Informed Drug Development (MIDD). This comes on the heels of ICH’s 11/2022 finalized concept
Drugs
FDA researchers say the alternative tools used by the agency to evaluate data reliability and integrity, good clinical practice (GCP) compliance, and subject safety during the Covid-19 public health emergency were “critical in informing the agency’s regulatory decisions for marketing applications while mitigating the spread of Covid-19.
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) 2022 annual report says FDA will continue to use remote regulatory assessments to augment on-site inspection activities. When Covid-19 restricted travel, the report says, OPQ turned to alternative tools such as requesting information from a facility instead of an inspection. “In
Biologics
CBER director Peter Marks told the Biopharma Congress on 2/13 that he wants to see something similar to the agency’s Project Orbis cancer program developed for cell and gene therapies as the involvement of other “high-income countries” could help attract developers. The FDA Oncology Center of Excellence
FDA Policy/General
A Los Angeles Times story carried by Yahoo! News, says FDA is “treading a fine line as it attempts to respond to misinformation on social media without amplifying it.” The article says that since Robert Califf was named agency commissioner over a year ago, FDA has set its sights on
FDA Policy/General
The U.S. Department of Justice (DoJ) says over $2.2 billion was collected in settlements and judgments against health care defendants under the False Claims Act during fiscal year 2022. “The government and whistleblowers were party to 351 settlements and judgments, the second-highest number of settlements and judgments
Biologics
A new journal article by CBER reviewers that looked at 24 advisory committee meetings held to discuss benefit-risk issues between 2009 and 2021 found that the two most frequently discussed considerations were “uncertainty about assessment of the safety profile” and “uncertainty about assessment of the benefit based on clinical
Devices
FDA has cleared a Hyperfine 510(k) for its upgraded Swoop AI-powered software for use with the Swoop Portable MR Imaging System. The software is intended to improve the image quality of the “diffusion-weighting imaging (DWI) sequence with increases in its signal-to-noise ratio,” the company says.
Drugs
FDA has accepted for review an Ocuphire Pharma NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for treating pharmacologically-induced mydriasis. The company says patients often are troubled by the effects of prolonged eye dilation, and a reversal drop would significantly improve patient experiences and productivity. The agency has set
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “FDA Advisory Committees; Information Collection Activities.” The agency is revising the collection to include reporting activities associated with guest speakers, who are occasionally asked to present technical and scientific data pertaining to matters being considered by a