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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 March 2023.
FDA Final Guidance
Q13 Continuous Manufacturing of Drug Substances and Drug Products (01-Mar-2023)
Download FDA Guidance
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry (10-Mar-2023)
Download FDA Guidance
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (16-Mar-2023)
Download FDA Guidance
Identification of Medicinal Products — Implementation and Use (30-Mar-2023)
Download FDA Guidance
FDA Draft Guidance:
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens (published 01-Mar-2023)
Draft FDA Guidance
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (published 15-Mar-2023)
Draft FDA Guidance
Pharmacogenomic Data Submissions (17-Mar-2023)
Draft FDA Guidance
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics Guidance for Industry (published 24-Mar-2023)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 03/01/2023
Drug Name: COMBOGESICNDA #209471
Active Ingredients: ACETAMINOPHEN; IBUPROFEN
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: AFT PHARMS LTD
Approval Date: 03/07/2023
Drug Name: NALOXONE HYDROCHLORIDENDA #208969
Active Ingredients: NALOXONE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMPHASTAR PHARMS INC
Approval Date: 03/09/2023
Drug Name: ZAVZPRETNDA #216386
Active Ingredients: ZAVEGEPANT HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: PFIZER
Approval Date: 03/10/2023
Drug Name: DAYBUENDA #217026
Active Ingredients: TROFINETIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ACADIA PHARMS INC
Approval Date: 03/16/2023
Drug Name: MEKINISTNDA #217513
Active Ingredients: TRAMETINIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: NOVARTIS
Approval Date: 03/16/2023
Drug Name: MEKINISTNDA #217513
Active Ingredients: TRAMETINIB DIMETHYL SULFOXIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: NOVARTIS
Approval Date: 03/16/2023
Drug Name: TAFINLARNDA #217514
Active Ingredients: DABRAFENIB MESYLATE
Submission Classification*:
Review Priority**: Priority
Company: NOVARTIS
Approval Date: 03/22/2023
Drug Name: ZYNYZBLA #761334
Active Ingredients: RETIFANLIMAB-DLWR
Submission Classification*:
Review Priority**:
Company: INCYTE CORP
Approval Date: 03/24/2023
Drug Name: JOENJANDA #217759
Active Ingredients: LENIOLISIB PHOSPHATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: PHARMING TECHNOLOGIES BV
Upcoming Advisory Board Meetings
04/12/2023- UPDATED INFORMATION: Meeting of the Nonprescription Drugs Advisory Committee Meeting- 08:30 AM EST to 05:30 PM EST
04/14/2023- Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Meeting- 09:00 AM EST to 04:00 PM EST
04/17/2023- UPDATED INFORMATION: Meeting of the Antimicrobial Drugs Advisory Committee Meeting 09:00 AM EST to 04:30 PM EST
04/19/2023- Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting- 09:00 AM EST to 05:30 PM EST
04/26/2023- Blood Products Advisory Committee Meeting- 09:30 AM EST to 01:00 PM EST
04/29/2023- Meeting of the Oncologic Drugs Advisory Committee Meeting 11:00 AM EST to 04:30 PM EST
Survey finds more trading partners are exchanging electronic product information (published 01-Mar-2023)
Read Article on RAPS.org
FDA seeks feedback on artificial intelligence in drug manufacturing (published 01-Mar-2023)
Read Article on RAPS.org
Opioids top FDA’s 2022 drug safety priorities report (published 02-Mar-2023)
Read Article on RAPS.org
Woodcock: Pending ORA reorg will 'modify things significantly' for all FDA regulated products (published 03-Mar-2023)
Read Article on RAPS.org
CBER’s first untitled letter of 2023 dings clinic over unlicensed stem cell products (published 06-Mar-2023)
Read Article on RAPS.org
Researchers call on FDA to get tough on accelerated approval labeling (published 06-Mar-2023)
Read Article on RAPS.org
FDA official warns manufacturers of common problems found in aseptic operations (published 06-Mar-2023)
Read Article on RAPS.org
FDA seeks 10% boost in Biden’s FY 2024 budget (published 09-Mar-2023)
Read Article on RAPS.org
EMA Q&A addresses submission of data elements for raw data pilot (published 10-Mar-2023)
Read Article on RAPS.org
Human factors guidance: Stakeholders ask for clarity, less burdensome approach (published 13-Mar-2023)
Read Article on RAPS.org
Advanced manufacturing: GAO, USP reports say regulatory enhancements needed (published 14-Mar-2023)
Read Article on RAPS.org
EMA-FDA parallel scientific advice program has ‘limited’ uptake (published 14-Mar-2023)
Read Article on RAPS.org
FDA warns pharmacy benefit company for distributing unapproved foreign drugs (published 14-Mar-2023)
Read Article on RAPS.org
FDA revises guidance on electronic systems and signatures in clinical trials (published 15-Mar-2023)
Read Article on RAPS.org
Pharma wants FDA’s IND reporting rule better aligned with ICH E2F (published 15-Mar-2023)
Read Article on RAPS.org
FDA issues guidance on developing long-acting local anesthetics (published 16-Mar-2023)
Read Article on RAPS.org
Industry requests more information from FDA on dosage and administration labeling (published 17-Mar-2023)
Read Article on RAPS.org
ICH adopts S12 guideline for gene therapies (published 20-Mar-2023)
Read Article on RAPS.org
FDA’s top cybersecurity officials discuss heightened threats, technology modernization (published 20-Mar-2023)
Read Article on RAPS.org
FDA issues guidance on submission of pharmacogenomic data (published 20-Mar-2023)
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NCI official raises concerns about FDA’s cancer drug dose optimization guidance (published 21-Mar-2023)
Read Article on RAPS.org
Stakeholders offer input on educational materials for rare disease drug development (published 22-Mar-2023)
Read Article on RAPS.org
DARWIN EU ‘ramping up quickly’ with more partners coming on board (published 23-Mar-2023)
Read Article on RAPS.org
Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs (published 23-Mar-2023)
Read Article on RAPS.org
Decentralized trials getting some attention on the international regulatory front (published 24-Mar-2023)
Read Article on RAPS.org
EMA official shares lessons learned from the COVID pandemic (published 24-Mar-2023)
Read Article on RAPS.org
FDA outlines plan for digital health technologies for clinical trials (published 24-Mar-2023)
Read Article on RAPS.org
FDA encourages RCTs in accelerated approval guidance for oncology (published 27-Mar-2023)
Read Article on RAPS.org
Pharma official: Expect “substantial” revision of ICH stability and specification guidelines (published 27-Mar-2023)
Read Article on RAPS.org
EMA’s quality innovation group helps to propel regulatory path for novel technologies (published 30-Mar-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