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ASCO Annual Meeting
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Advancing Oncology Therapies for Patients in Need
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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.
New FDA Guidance Documents:
Study Data Technical Conformance Guide - Technical Specifications Document (published 12-Nov-2021)
New Draft Guidance Documents: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Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry: Draft Guidance for Industry (published 29-Nov-2021)
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
GDUFA III commitment letter details coming changes to FDA's generic review program (published 02-Nov-2021)
In US, unlicensed stem cell clinic numbers keep climbing (published 04-Nov-2021)
FDA taking incremental approach to launching KASA reviews (published 05-Nov-2021)
FDA releases 4 dozen new and updated PSGs (published 08-Nov-2021)
EMA to offer recommendation on national use for Merck's molnupiravir (published 08-Nov-2021)
Real-world evidence from EHR supports antimicrobial resistance fight (published 08-Nov-2021)
White paper bolsters ctDNA as potential 'early endpoint' in cancer approvals (published 09-Nov-2021)
Friends of Cancer Research urges early dose-finding studies to reduce treatment toxicity (published 10-Nov-2021)
Industry calls for technical, scope changes in ICH S12 guideline (published 10-Nov-2021)
FDA touts success and challenges in biosimilar development (published 10-Nov-2021)
Study: RWD not ready for postapproval prime time (published 11-Nov-2021)
Biden nominates Califf as FDA commissioner (published 12-Nov-2021)
This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more (published 12-Nov-2021)
FDA could do more to enforce ClinicalTrials.gov reporting requirements (published 15-Nov-2021)
FDA officials address common pitfalls affecting post-approval change applications (published 15-Nov-2021)
Long-awaited Cures 2.0 bill unveiled (published 16-Nov-2021)
CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies (published 16-Nov-2021)
FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA (published 17-Nov-2021)
GDUFA III fiscal details emerge (published 18-Nov-2021)
GAO: Pathway for antimicrobial drug development leads to few approvals (published 22-Nov-2021)
EMA provides advice on using molnupiravir; will soon render decision on J&J’s COVID vaccine booster (published 22-Nov-2021)
FDA says it far exceeded its projections for inspections in FY2021 (published 22-Nov-2021)
FDA shares research to improve dose selection in pediatric drug development (published 23-Nov-2021)
FDA suggests alternative approaches for nitrosamine risk assessments (published 23-Nov-2021)
FDA offers draft guidance for registries as RWD (published 29-Nov-2021)
ICH recaps progress made over past year, charts new topics (published 29-Nov-2021)
Public-private initiative expands support for NGS tests (published 30-Nov-2021)
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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