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February 2022
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 2022.
New FDA Guidance Documents:
Population Pharmacokinetics: Guidance for Industry (published 03-Feb-2022)
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic: Guidance for Industry (published 04-Feb-2022)
New Draft Guidance Documents:
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry (published 03-Feb-2022)
Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry (published 03-Feb-2022)
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Draft Guidance for Industry (published 07-Feb-2022)
Monthly FDA Approvals:
RUZURGINDA #209321
Type 2 - New Active IngredientAMIFAMPRIDINEApproved on 01-Feb-2022
FLEQSUVYNDA #215602
Type 3 - New Dosage FormBACLOFENApproved on 04-Feb-2022
ENJAYMOBLA #761164SUTIMLIMAB-JOMEApproved on 04-Feb-2022
PYRUKYNDNDA #216196
Type 1 - New Molecular EntityMITAPIVATApproved on 17-Feb-2022
NEPHROSCANNDA #214993
Type 5 - New Formulation or New ManufacturerTECHNETIUM TC-99M SUCCIMER KITApproved on 18-Feb-2022
NORLIQVANDA #214439
Type 5 - New Formulation or New ManufacturerAMLODIPINEApproved on 24-Feb-2022
RELEUKOBLA #761082FILGRASTIM-AYOWApproved on 25-Feb-2022
Upcoming Advisory Committee Meeting:
March 10th, 2022: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting-10:00 AM EST- 1:30 PM EST (CBER)
March 30th, 2022: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee- 10 AM EST- 4:30 PM EST (CDER)
RAC receives accreditation from National Commission for Certifying Agencies (published 01-Feb-2022)
FDA finalizes population pharmacokinetics guidance (published 03-Feb-2022)
CDER unveils 30 new planned guidance documents in 2022 agenda (published 07-Feb-2022)
EMA offers more clarity on controlling multiple nitrosamines (published 07-Feb-2022)
FDA issues clinical pharmacology draft guidance for antibody-drug conjugates (published 08-Feb-2022)
FDA urges sponsors to find alternatives to nonhuman primates for toxicity studies (published 08-Feb-2022)
FDA offers insights on blood pressure studies, immunogenicity labeling (published 09-Feb-2022)
FDA officials, advisors cast doubt on foreign-only clinical strategy (published 10-Feb-2022)
Industry weighs in on the EU’s pandemic-related flexibilities (published 17-Feb-2022)
EMA releases 2021 human medicines highlights report (published 21-Feb-2022)
CBER warns Massachusetts-based CRO over GLP issues (published 23-Feb-2022)
FOCR calls for flexibility in review of companion diagnostics for rare biomarkers (published 24-Feb-2022)
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Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
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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