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Chief Medical Officer Summit -CMO 360°
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December 2021
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 December 2021.
New FDA Guidance Documents:
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers (published 27-Dec-2021)
Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry: Guidance for Industry (published 10-Dec-2021)
Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency: Guidance for Industry and Health Care Professionals (published 10-Dec-2021)
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (published 09-Dec-2021)
New Draft Guidance Documents:
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Draft Guidance for Industry, Investigators, and Other Stakeholders (published 22-Dec-2021)
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry: Draft Guidance for Industry (published 10-Dec-2021)
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment: Draft Guidance for Industry (published 09-Dec-2021)
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry (published 08-Dec-2021)
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators: Draft Guidance for Industry (published 07-Dec-2021)
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry (published 07-Dec-2021)
Monthly FDA Approvals:
XACIATONDA #215650
Type 5 - New Formulation or New Manufacturer
CLINDAMYCIN PHOSPHATE
Approved on 07-Dec-2021
ENTADFINDA #215423
Type 4 - New Combination
FINASTERIDE; TADALAFIL
Approved on 09-Dec-2021
TARPEYONDA #215935
Type 5 - New Formulation or New Manufacturer
BUDESONIDE
Approved on 15-Dec-2021
DARTISLA ODTNDA #215019
Type 3 - New Dosage Form
GLYCOPYRROLATE
Approved on 16-Dec-2021
BORTEZOMIBNDA #209191
Type 5 - New Formulation or New Manufacturer
BORTEZOMIB
Approved on 17-Dec-2021
LANREOTIDE ACETATENDA #215395
Type 5 - New Formulation or New Manufacturer
LANREOTIDE ACETATE
Approved on 17-Dec-2021
OXBRYTANDA #216157
Type 3 - New Dosage Form
VOXELOTOR
Approved on 17-Dec-2021
VYVGARTBLA #761195
EFGARTIGIMOD ALFA
Approved on 17-Dec-2021
REZVOGLARBLA #761215
INSULIN GLARGINE-AGLR
Approved on 17-Dec-2021
YUSIMRYBLA #761216
ADALIMUMAB-AQVH
Approved on 17-Dec-2021
TEZSPIREBLA #761224
TEZEPELUMAB-EKKO
Approved on 17-Dec-2021
APRETUDENDA #215499
Type 5 - New Formulation or New Manufacturer
CABOTEGRAVIR
Approved on 20-Dec-2021
XARELTONDA #215859
Type 3 - New Dosage Form
RIVAROXABAN
Approved on 20-Dec-2021
LEQVIONDA #214012
Type 1 - New Molecular Entity
INCLISIRAN
Approved 22-Dec-2021
ADBRYBLA #761180
TRALOKINUMAB
Approved on 27-Dec-2021
CABAZITAXELNDA #207949
Type 5 - New Formulation or New Manufacturer
CABAZITAXEL
Approved 29-Dec-2021
EU official says ICH Q6B is outdated and needs revision (published 01-Dec-2021)
New reports address generics pricing, innovation in the EU (published 01-Dec-2021)
FDA announces FY 2022 GDUFA science and research priorities (published 02-Dec-2021)
November’s Regulatory Focus: Global development for pediatric products (published 06-Dec-2021)
Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending (published 06-Dec-2021)
ICMRA, WHO take stock of regulatory flexibilities (published 06-Dec-2021)
EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns (published 07-Dec-2021)
FDA rolls out more guidance on 'N of 1' gene therapies (published 07-Dec-2021)
PhRMA, AdvaMed weigh in on safety reporting draft guidance (published 08-Dec-2021)
Consensus lacking on ‘value’ for new anticancer drugs (published 08-Dec-2021)
FDA issues draft guidance on study designs using real-world data (published 09-Dec-2021)
FDA issues final guidance on CMC postapproval changes for annual reports (published 09-Dec-2021)
Gene therapy developers can expect less hand-holding from OTAT (published 10-Dec-2021)
EC report details EU medicine shortages, offers potential solutions (published 10-Dec-2021)
FDA issues final guidance on pediatric anti-infective development (published 13-Dec-2021)
Califf skates through nomination hearing (published 14-Dec-2021)
ICMRA: Remote inspections can complement, but not replace, onsite inspections (published 14-Dec-2021)
FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps (published 14-Dec-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