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Chief Medical Officer Summit -CMO 360°
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in February 2023.
FDA Final Guidance
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act (published 09-Feb-2023)
Download FDA Guidance
FDA Draft Guidance:
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (published 01-Feb-2023)
Draft FDA Guidance
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development (published 10-Feb-2023)
Draft FDA Guidance
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment Guidance for Industry (published 24-Feb-2023)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 02/01/2023
Drug Name: ATORVALIQNDA #213260
Active Ingredients: ATORVASTATIN CALCIUM
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CMP DEV LLC
Approval Date: 02/01/2023
Drug Name: JESDUVROQNDA #216951
Active Ingredients: DAPRODUSTAT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: GLAXOSMITHKLINE
Approval Date: 02/06/2023
Drug Name: PACLITAXELNDA #216338
Active Ingredients: PACLITAXEL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: TEVA PHARMS
Approval Date: 02/08/2023
Drug Name: FENTANYL CITRATENDA #215870
Active Ingredients: FENTANYL CITRATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: EXELA PHARMA
Approval Date: 02/16/2023
Drug Name: LAMZEDEBLA #761278
Active Ingredients: VELMANASE ALFA-TYCV
Submission Classification*:
Review Priority**:
Company: CHIESI FARMACEUTICI SPA
Approval Date: 02/17/2023
Drug Name: AUSTEDO XRNDA #216354
Active Ingredients: DEUTETRABENZINE
Submission Classification*:
Review Priority**: Standard
Company: TEVA NEUROSCIENCE INC
Approval Date: 02/17/2023
Drug Name: FILSPARINDA #216403
Active Ingredients: SPARSENTAN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: TRAVERE
Approval Date: 02/17/2023
Drug Name: SYFOVRENDA #217171
Active Ingredients: PEGCETACOPLAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: APELLIS PHARMS
Approval Date: 02/23/2023
Drug Name: PREVDUONDA #216903
Active Ingredients: NEOSTIGMINE METHYLSULFATE AND GLYCOPYRROLATE
Submission Classification*:
Review Priority**: Standard
Company: SLAYBACK PHARMA LLC
Approval Date: 02/28/2023
Drug Name: SKYCLARYSNDA #216718
Active Ingredients: OMAVELOXOLONE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: REATA PHARMACEUTICALS INC
Upcoming Advisory Board Meetings
03/07/2023- Vaccines and Related Biological Products Advisory Committee Meeting– 09:00 AM EST to 03:30 PM EST- CBER
03/09/2023- Oncologic Drugs Advisory Committee Meeting – 12:00 PM EST to 05:00 PM EST- CDER
03/22/2023- Peripheral and Central Nervous System Drugs Advisory Committee Meeting- 10:00 AM EDT to 06:00 PM EDT- CDER
03/28/2023- 03/29/2023- Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting- 10:00 AM EDT- 04:00 PM EDT- CDER
FDA draft guidance addresses use of external controls to assess effectiveness of new drugs and biologics (published 02-Feb-2023)
Read Article on RAPS.org
FDA draft guidance addresses clinical development of drugs to treat early Lyme disease (published 02-Feb-2023)
Read Article on RAPS.org
EMA wants participants to serve on clinical trial multistakeholder forum (published 03-Feb-2023)
Read Article on RAPS.org
EMA launches ‘stepwise PIP’ pilot (published 06-Feb-2023)
Read Article on RAPS.org
DSCSA: New interoperability ‘blueprint’ released (published 06-Feb-2023)
Read Article on RAPS.org
EMA to launch scientific advice pilot for high-risk devices in late February (published 07-Feb-2023)
Read Article on RAPS.org
Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence (published 07-Feb-2023)
Read Article on RAPS.org
FDA officials offer advice on gene therapy trials (published 08-Feb-2023)
Read Article on RAPS.org
Califf addresses inspections, staffing and COVID response in House hearing (published 08-Feb-2023)
Read Article on RAPS.org
Industry group petitions FDA to withdraw CDS guidance (published 09-Feb-2023)
Read Article on RAPS.org
FDA outlines criteria for conducting long-term neurodevelopmental safety studies in neonates (published 10-Feb-2023)
Read Article on RAPS.org
Clinical data consortium seeks to establish best practices for supplemental controls (published 13-Feb-2023)
Read Article on RAPS.org
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints (published 13-Feb-2023)
Read Article on RAPS.org
Study finds manufacturers spend more to advertise less beneficial drugs (published 13-Feb-2023)
Read Article on RAPS.org
Top FDA official interested in ‘Project Orbis’ for cell and gene therapies (published 13-Feb-2023)
Read Article on RAPS.org
Study: One-fifth of recent FDA approved drugs not authorized, reimbursed in other countries (published 14-Feb-2023)
Read Article on RAPS.org
FDA cites drug, hand sanitizer and face mask firms with CGMP violations (published 14-Feb-2023)
Read Article on RAPS.org
Califf: Advisory committee meeting structure needs an overhaul (published 14-Feb-2023)
Read Article on RAPS.org
Study: Extrapolation used in more than half of pediatric drug labeling changes (published 15-Feb-2023)
Read Article on RAPS.org
GAO calls for better FDA oversight of IRBs (published 20-Feb-2023)
Read Article on RAPS.org
HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules (published 21-Feb-2023)
Read Article on RAPS.org
Transparency, transition period addressed in new EMA Q&A guidance on CTR implementation (published 21-Feb-2023)
Read Article on RAPS.org
Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal (published 23-Feb-2023)
Read Article on RAPS.org
Industry groups call for changes in ICH M11 guideline on harmonized protocols (published 23-Feb-2023)
Read Article on RAPS.org
PhRMA official discusses legislative priorities, lessons from the pandemic (published 23-Feb-2023)
Read Article on RAPS.org
Billy Dunn, FDA’s top neuroscience official to depart agency (published 27-Feb-2023)
Read Article on RAPS.org
FDA plans to launch communications pilot for promising rare disease gene therapies (published 27-Feb-2023)
Read Article on RAPS.org
ICH to adopt final guideline on drug interaction studies early next year (published 27-Feb-2023)
Read Article on RAPS.org
FDA issues guidance on drug development for neovascular age-related AMD (published 28-Feb-2023)
Read Article on RAPS.org
- Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
- Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
- Download our COVID-19 Guide on Strategies For Success During the COVID-19 Era
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER