Regulatory Guidance Monthly Review - Dec 2021

December 2021 


Veristat_SM_December2021 Reg

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.

 

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New FDA Guidance Documents:

 

Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers (published 27-Dec-2021)

Download FDA Guidance

Q3C(R8) Impurities: Guidance for Residual Solvents   Guidance for Industry:  Guidance for Industry (published 10-Dec-2021)

Download FDA Guidance

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)

Download FDA Guidance

CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (published 09-Dec-2021)

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New Draft Guidance Documents:

 

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Draft Guidance for Industry, Investigators, and Other Stakeholders (published 22-Dec-2021)

Draft FDA Guidance

Cover Letter Attachments for Controlled Correspondences and ANDA Submissions   Guidance for Industry: Draft Guidance for Industry (published 10-Dec-2021)

Draft FDA Guidance

Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment: Draft Guidance for Industry (published 09-Dec-2021)

Draft FDA Guidance

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Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry (published 08-Dec-2021)

Draft FDA Guidance

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Life-Threatening Diseases:  Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators: Draft Guidance for Industry (published 07-Dec-2021)

Draft FDA Guidance

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)

Draft FDA Guidance

 

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


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

EU official says ICH Q6B is outdated and needs revision (published 01-Dec-2021)

Read Article on RAPS.org

 

New reports address generics pricing, innovation in the EU (published 01-Dec-2021)

Read Article on RAPS.org

 

FDA announces FY 2022 GDUFA science and research priorities (published 02-Dec-2021)

Read Article on RAPS.org

 

November’s Regulatory Focus: Global development for pediatric products (published 06-Dec-2021)

Read Article on RAPS.org

 

Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending (published 06-Dec-2021)

Read Article on RAPS.org

 

ICMRA, WHO take stock of regulatory flexibilities (published 06-Dec-2021)

Read Article on RAPS.org

 

EMA responds to MEPs’ inquiry on COVID vaccines, data integrity concerns (published 07-Dec-2021)

Read Article on RAPS.org

 

FDA rolls out more guidance on 'N of 1' gene therapies (published 07-Dec-2021)

Read Article on RAPS.org

 

PhRMA, AdvaMed weigh in on safety reporting draft guidance (published 08-Dec-2021)

Read Article on RAPS.org

 

Consensus lacking on ‘value’ for new anticancer drugs (published 08-Dec-2021)

Read Article on RAPS.org

 

FDA issues draft guidance on study designs using real-world data (published 09-Dec-2021)

Read Article on RAPS.org

 

FDA issues final guidance on CMC postapproval changes for annual reports (published 09-Dec-2021)

Read Article on RAPS.org

 

Gene therapy developers can expect less hand-holding from OTAT (published 10-Dec-2021)

Read Article on RAPS.org

 

EC report details EU medicine shortages, offers potential solutions (published 10-Dec-2021)

Read Article on RAPS.org

 

FDA issues final guidance on pediatric anti-infective development (published 13-Dec-2021)

Read Article on RAPS.org

 

Califf skates through nomination hearing (published 14-Dec-2021)

Read Article on RAPS.org

 

ICMRA: Remote inspections can complement, but not replace, onsite inspections (published 14-Dec-2021)

Read Article on RAPS.org

 

FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps (published 14-Dec-2021)

Read Article on RAPS.org

 

 


 

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