Regulatory Guidance Monthly Review - Jan2022

January 2022 


Social Media_Assets_Jan 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.

 

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New FDA Guidance Documents:

 

Investigational COVID-19 Convalescent Plasma:  Guidance for Industry (published 07-Jan-2022)

Download FDA Guidance

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)

Download FDA Guidance

Principles of Premarket Pathways for Combination Products:  Guidance for Industry and FDA Staff (published 26-Jan-2022)

Download FDA Guidance

 

New Draft Guidance Documents:

 

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Draft Guidance for Industry, Investigators, and Other Stakeholders (published 21-Jan-2022)

Draft FDA Guidance

 

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)


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

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)

Read Article on RAPS.org

 

FDA approved more first-in-class drugs, gave more accelerated approvals in 2021 (published 07-Jan-2022)

Read Article on RAPS.org

 

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)

Read Article on RAPS.org

 

Senate committee advances Califf’s nomination as FDA commissioner (published 13-Jan-2022)

Read Article on RAPS.org

 

WHO charts path to convergence on cell and gene therapies (published 14-Jan-2022)

Read Article on RAPS.org

 

EU launches clinical trials transformation initiative (published 18-Jan-2022)

Read Article on RAPS.org

 

Califf, experts eye legislative fix for accelerated approval program (published 19-Jan-2022)

Read Article on RAPS.org

 

FDA offers examples of innovative study designs accepted into CID pilot (published 20-Jan-2022)

Read Article on RAPS.org

 

FDA outlines rules for ‘portions’ of official samples in draft Q&A guidance (published 24-Jan-2022)

Read Article on RAPS.org

 

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)

Read Article on RAPS.org

 

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)

Read Article on RAPS.org

 

FDA officials look outward to improve the expedited drug approval process (published 31-Jan-2022)

Read Article on RAPS.org

 

FDA finalizes guidance on premarket review of combination products (published 31-Jan-2022)

Read Article on RAPS.org

 

ICH guide provides clarity on estimands, sensitivity analyses (published 31-Jan-2022)

Read Article on RAPS.org


 

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