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Chief Medical Officer Summit -CMO 360°
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January 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 January 2022.
New FDA Guidance Documents:
Investigational COVID-19 Convalescent Plasma: Guidance for Industry (published 07-Jan-2022)
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH): Guidance for Industry Technical Specifications Document (published 21-Jan-2022)
Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff (published 26-Jan-2022)
New Draft Guidance Documents:
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Draft Guidance for Industry, Investigators, and Other Stakeholders (published 21-Jan-2022)
Monthly FDA Approvals:
QUVIVIQNDA #214985
Type 1 - New Molecular Entity
DARIDOREXANT HYDROCHLORIDE
Approved on 07-Jan-2022
RYALTRISNDA #211746
Type 4 - New Combination
MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
Approved on 13-Jan-2022
CIBINQONDA #213871
Type 1 - New Molecular Entity
ABROCITINIB
Approved on 14-Jan-2022
HYDROXYCHLOROQUINE SULFATENDA #214581
Type 5 - New Formulation or New Manufacturer
HYDROXYCHLOROQUINE SULFATE
Approved on 14-Jan-2022
DAPZURA RTNDA #213645
Type 5 - New Formulation or New Manufacturer
DAPTOMYCIN
Approved on 25-Jan-2022
KIMMTRAKBLA #761228
TEBENTAFUSP-TEBN
Approved on 25-Jan-2022
VABYSMOBLA #761235
FARICIMAB-SVOA
Approved on 28-Jan-2022
CITALOPRAMNDA #215428
Type 2 - New Active Ingredient and Type 3 - New Dosage Form
CITALOPRAM HYDROBROMIDE
Approved on 31-Jan-2022
Upcoming Advisory Committee Meeting:
February 10, 2022: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 02/10/2022 - 02/10/2022 (CDER)
ICH releases revised Q9 guideline to improve risk assessments (published 03-Jan-2022)Read Article on RAPS.org
FDA temporarily halts inspections due to omicron (published 05-Jan-2022)Read Article on RAPS.org
Digital health tech in clinical investigations: FDA issues draft guidance (published 05-Jan-2022)
FDA approved more first-in-class drugs, gave more accelerated approvals in 2021 (published 07-Jan-2022)
European Commission creates rules for allocating clinical trial safety oversight (published 12-Jan-2022)Read Article on RAPS.org
Stakeholders seek clarity on FDA cell and gene therapy draft guidance (published 13-Jan-2022)
Senate committee advances Califf’s nomination as FDA commissioner (published 13-Jan-2022)
WHO charts path to convergence on cell and gene therapies (published 14-Jan-2022)
EU launches clinical trials transformation initiative (published 18-Jan-2022)
Califf, experts eye legislative fix for accelerated approval program (published 19-Jan-2022)
FDA offers examples of innovative study designs accepted into CID pilot (published 20-Jan-2022)
FDA outlines rules for ‘portions’ of official samples in draft Q&A guidance (published 24-Jan-2022)
CBER outlines another slim guidance agenda for 2022 (published 25-Jan-2022)Read Article on RAPS.org
FDA issues trio of guidances aimed at boosting generic competition, reducing review cycles (published 26-Jan-2022)Read Article on RAPS.org
Industry calls for flexibility on RWD data sources, validation (published 26-Jan-2022)Read Article on RAPS.org
Aurobindo warned for lax investigations, repeat GMP violations (published 26-Jan-2022)
EU foresees reenergized clinical trial sector as new regulations take effect (published 27-Jan-2022)Read Article on RAPS.org
Orphan drug experts discuss new book on developing rare disease treatments (published 27-Jan-2022)
FDA officials look outward to improve the expedited drug approval process (published 31-Jan-2022)
FDA finalizes guidance on premarket review of combination products (published 31-Jan-2022)
ICH guide provides clarity on estimands, sensitivity analyses (published 31-Jan-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 Pathwaysfor 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