This Week at FDA: PDUFA and BsUFA hires, cannabis guidance, and more

This Week at FDAThis Week at FDA | 27 January 2023 |  By 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA gave its first quarterly update on its hiring goals under its prescription drug and biosimilar user fee programs. The agency also finalized guidance on quality considerations for cannabis and cannabis-derived drugs and said that a new regulatory pathway is needed for cannabidiol (CBD) products.
Under the new Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) agreements, FDA committed to hiring new staff for its drugs and biologics product centers. So far, FDA said it has hired 71 of the 210 (34%) of the PDUFA VII positions it committed to fill in FY2023, including 58 CBER and 13 CDER hires. The agency is further behind on filling BsUFA III roles; FDA has hired 3 of the 14 (21%) full time equivalents (FTEs) it needs to hire in FY2023 to meet its goal for the year.
Earlier this week, FDA finalized its guidance on quality considerations for clinical research involving cannabis and cannabis-derived compounds. The guidance offers clarifications about sources of cannabis for clinical research and provides new resources on the agency’s expectations for investigational new drug applications (INDs) at various stages of development. Additionally, FDA said the guidance provides recommendations on calculating delta-9 THC content.
The agency also announced that it has concluded that a new regulatory pathway is needed to oversee CBD products, and that it plans to work with Congress on legislation to support such a pathway.
After warning that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) may not work against SARS-CoV-2 Omicron subvariant XBB.1.5, the agency on Thursday announced that the monoclonal antibody is not currently authorized in the US until further notice. “Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants. According to the most recent CDC Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the US,” FDA said.
FDA’s Office of Clinical Pharmacology released its 2022 Annual Report earlier this week, highlighting the office’s activities during the previous year.
Reuters reports that FDA will work with other global regulators and the World Health Organization to investigate contaminated cough syrups sold in countries including Gambia, Indonesia and Uzbekistan.
In the wake of several high-profile controversies involving foods, Frank Yiannas, deputy commissioner for food policy and response has resigned from the agency, effective 24 February, according to Politico.
The National Institutes of Health on Wednesday announced that has launched the Center for Biomedical Engineering Technology Acceleration (BETA Center) within the National Institute of Biomedical Imaging and Bioengineering (NIBIB). “The center will incorporate a focused engineering approach to accelerate the development, validation and dissemination of cutting-edge technologies. Areas of emphasis will include biomedical imaging, biosensing, engineered and synthetic biology, nanomaterials and biomaterials, artificial intelligence, modeling, computation and informatics,” NIH said.
Drugs & biologics
FDA’s Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee will hold a joint meeting on 20 March to review Harm Reduction Therapeutics, Inc.’s new drug application for a nonprescription naloxone nasal spray for the emergency treatment of opioid overdose. If approved, FDA said the drug would be the first drug to enter a new therapeutic category for nonprescription drugs.
BioCentury reports that the Biotechnology Innovation Organization (BIO) plans to push back on FDA’s new authority to require that confirmatory clinical trials be ongoing at the time of accelerated approval.
FDA announced on Friday that it plans to issue a draft guidance on developing drugs to treat acromegaly, a rare disorder caused by excess growth hormone that can cause enlarged hands and feet, among other symptoms.
The agency also released data on its generic drug activities for the month of December 2022. In December, FDA approved 52 abbreviated new drug applications (ANDAs) and tentatively approved seven applications.
This week, FDA announced that it has launched its joint eSTAR pilot with Health Canada after selecting nine participants to join the pilot. Under the pilot, participants can submit a single eSTAR to both FDA and Health Canada.
CDRH has released its 2022 Annual Report, offering an overview of the center’s pandemic response, the MDUFA V agreement, device innovation and safety-related activities in 2022.
The agency also identified Class I recalls for Emergent’s reactive skin decontamination lotion kits, Datascope/Getinge Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) systems, and LivaNova’s LifeSPARC system.


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