Regulatory Guidance Monthly Review

February 2022 


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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 2022.

 

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New FDA Guidance Documents:

 

Population Pharmacokinetics:  Guidance for Industry (published 03-Feb-2022)

Download FDA Guidance

Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic:  Guidance for Industry (published 04-Feb-2022)

Download FDA Guidance

 

 

New Draft Guidance Documents: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Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry (published 03-Feb-2022)

Draft FDA Guidance

 

Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry (published 03-Feb-2022)

Draft FDA Guidance

Clinical Pharmacology Considerations for Antibody-Drug Conjugates  Guidance for Industry: Draft Guidance for Industry (published 07-Feb-2022)

Draft FDA Guidance

 

 

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)


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

RAC receives accreditation from National Commission for Certifying Agencies (published 01-Feb-2022)

Read Article on RAPS.org

 

FDA finalizes population pharmacokinetics guidance (published 03-Feb-2022)

Read Article on RAPS.org

CDER unveils 30 new planned guidance documents in 2022 agenda (published 07-Feb-2022)

Read Article on RAPS.org

EMA offers more clarity on controlling multiple nitrosamines (published 07-Feb-2022)

Read Article on RAPS.org

FDA issues clinical pharmacology draft guidance for antibody-drug conjugates (published 08-Feb-2022)

Read Article on RAPS.org

FDA urges sponsors to find alternatives to nonhuman primates for toxicity studies (published 08-Feb-2022)

Read Article on RAPS.org

FDA offers insights on blood pressure studies, immunogenicity labeling (published 09-Feb-2022)

Read Article on RAPS.org

FDA officials, advisors cast doubt on foreign-only clinical strategy (published 10-Feb-2022)

Read Article on RAPS.org

Industry weighs in on the EU’s pandemic-related flexibilities (published 17-Feb-2022)

Read Article on RAPS.org

EMA releases 2021 human medicines highlights report (published 21-Feb-2022)

Read Article on RAPS.org

CBER warns Massachusetts-based CRO over GLP issues (published 23-Feb-2022)

Read Article on RAPS.org

FOCR calls for flexibility in review of companion diagnostics for rare biomarkers (published 24-Feb-2022)

Read Article on RAPS.org

 


 

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