Regulatory Guidance Monthly Review - Nov 2021

November 2021 


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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 November 2021.

 

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New FDA Guidance Documents:

 

Study Data Technical Conformance Guide - Technical Specifications Document (published 12-Nov-2021)

Download FDA Guidance

 

New Draft Guidance Documents:

 

Real-World Data:  Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products  Guidance for Industry: Draft Guidance for Industry (published 29-Nov-2021)

Draft FDA Guidance

 

Monthly FDA Approvals:

 

DYANAVELXRNDA #210526

Type 3 - New Dosage Form

AMPHETAMINE

Approved on 04-Nov-2021

 

YUTREPIANDA   #213005

Type 3 - New Dosage Form

TREPROSTINIL

Approved on 04-Nov-2021

EPRONTIANDA   #214679

Type 3 - New Dosage Form

TOPIRAMATE

Approved on 05-Nov-2021

DHIVYNDA   #214869

Type 5 - New Formulation or New Manufacturer

CARBIDOPA; LEVODOPA

Approved on 12-Nov-2021

BENDAMUSTINE HYDROCHLORIDENDA   #215668

Type 5 - New Formulation or New Manufacturer

BENDAMUSTINE HYDROCHLORIDE

Approved on 12-Nov-2021

BESREMIBLA   #761166

ROPEGINTERFERON ALFA-2B-NJFT

Approved on 12-Nov-2021

FYARRONDA   #213312

Type 5 - New Formulation or New Manufacturer

SIROLIMUS ALBUMIN-BOUND NANOPARTICLES

Approved on 22-Nov-2021

LYVISPAHNDA   #215422

Type 3 - New Dosage Form

BACLOFEN

Approved on 22-Nov-2021

LIVTENCITYNDA   #215596

Type 1 - New Molecular Entity

MARIBAVIR

Approved on 23-Nov-2021

CYTALUXNDA   #214907

Type 1 - New Molecular Entity

PAFOLACIANINE

Approved on 29-Nov-2021


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

GDUFA III commitment letter details coming changes to FDA's generic review program (published 02-Nov-2021)

Read Article on RAPS.org

In US, unlicensed stem cell clinic numbers keep climbing (published 04-Nov-2021)

Read Article on RAPS.org

FDA taking incremental approach to launching KASA reviews (published 05-Nov-2021)

Read Article on RAPS.org

FDA releases 4 dozen new and updated PSGs (published 08-Nov-2021)

Read Article on RAPS.org

EMA to offer recommendation on national use for Merck's molnupiravir (published 08-Nov-2021)

Read Article on RAPS.org

Real-world evidence from EHR supports antimicrobial resistance fight (published 08-Nov-2021)

Read Article on RAPS.org

White paper bolsters ctDNA as potential 'early endpoint' in cancer approvals (published 09-Nov-2021)

Read Article on RAPS.org

Friends of Cancer Research urges early dose-finding studies to reduce treatment toxicity (published 10-Nov-2021)

Read Article on RAPS.org

Industry calls for technical, scope changes in ICH S12 guideline (published 10-Nov-2021)

Read Article on RAPS.org

FDA touts success and challenges in biosimilar development (published 10-Nov-2021)

Read Article on RAPS.org

Study: RWD not ready for postapproval prime time (published 11-Nov-2021)

Read Article on RAPS.org

Biden nominates Califf as FDA commissioner (published 12-Nov-2021)

Read Article on RAPS.org

This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more (published 12-Nov-2021)

Read Article on RAPS.org

FDA could do more to enforce ClinicalTrials.gov reporting requirements (published 15-Nov-2021)

Read Article on RAPS.org

FDA officials address common pitfalls affecting post-approval change applications (published 15-Nov-2021)

Read Article on RAPS.org

Long-awaited Cures 2.0 bill unveiled (published 16-Nov-2021)

Read Article on RAPS.org

CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies (published 16-Nov-2021)

Read Article on RAPS.org

FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA (published 17-Nov-2021)

Read Article on RAPS.org

GDUFA III fiscal details emerge (published 18-Nov-2021)

Read Article on RAPS.org

GAO: Pathway for antimicrobial drug development leads to few approvals (published 22-Nov-2021)

Read Article on RAPS.org

EMA provides advice on using molnupiravir; will soon render decision on J&J’s COVID vaccine booster (published 22-Nov-2021)

Read Article on RAPS.org

FDA says it far exceeded its projections for inspections in FY2021 (published 22-Nov-2021)

Read Article on RAPS.org

FDA shares research to improve dose selection in pediatric drug development (published 23-Nov-2021)

Read Article on RAPS.org

FDA suggests alternative approaches for nitrosamine risk assessments (published 23-Nov-2021)

Read Article on RAPS.org

FDA offers draft guidance for registries as RWD (published 29-Nov-2021)

Read Article on RAPS.org

ICH recaps progress made over past year, charts new topics (published 29-Nov-2021)

Read Article on RAPS.org

Public-private initiative expands support for NGS tests (published 30-Nov-2021)

Read Article on RAPS.org

 

 


 

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