Regulatory Guidance Monthly Review - April 2022

April 2022 


Social Media_Assets_April 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 April 2022.

 

Blog Image-Regulatory Guidanc eMonthly_FDAupdates-1

 

New FDA Guidance Documents:

 

Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (published 07-Apr-2022)

Download FDA Guidance

 

E8(R1) General Considerations for Clinical Studies (published 08-Apr-2022)

Download FDA Guidance

 

Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (published 11-Apr-2022)

Download FDA Guidance

Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C:  Guidance for Industry and FDA Staff (published 15-Apr-2022)

Download FDA Guidance

 

Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (published 21-Apr-2022)

Download FDA Guidance

 

Providing Submissions in Electronic Format — Postmarketing Safety Reports (published 27-Apr-2022)

Download FDA Guidance

Electronic Submission of IND Safety Reports Technical Conformance Guide :  Guidance for Industry (published 29-Apr-2022)

Download FDA Guidance

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (published 29-Apr-2022)

Download FDA Guidance

E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility (published 29-Apr-2022)

Download FDA Guidance

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility (published 29-Apr-2022)

Download FDA Guidance

 

 

New Draft Guidance Documents:

M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES: Draft Guidance for Industry (published 06-Apr-2022)

Draft FDA Guidance

 

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Draft Guidance for Industry (published 07-Apr-2022)

Draft FDA Guidance

 

Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability: Draft Guidance for Industry (published 13-Apr-2022)

Draft FDA Guidance

Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet (published 15-Apr-2022)

Draft FDA Guidance

Ulcerative Colitis:  Developing Drugs for Treatment (published 28-Apr-2022)

Draft FDA Guidance

Crohn’s Disease:  Developing Drugs for Treatment (published 28-Apr-2022)

Draft FDA Guidance

 

 

Monthly FDA Approvals:

 

Approval Date: 04/05/2022
Drug Name: VIJOICENDA #215039
Active Ingredients: ALPELISIB
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Priority
Company: NOVARTIS PHARMS CORP


Approval Date: 04/05/2022
Drug Name: IGALMINDA #215390
Active Ingredients: DEXMEDETOMIDINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: BIOXCEL THERAPEUTICS, INC.


Approval Date: 04/08/2022
Drug Name: BENDAMUSTINE HYDROCHLORIDENDA #215033
Active Ingredients: BENDAMUSTINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: APOTEX INC


Approval Date: 04/13/2022
Drug Name: ALYMSYSBLA #761231
Active Ingredients: BEVACIZUMAB-MALY
Submission Classification*:
Review Priority**:
Company: AMNEAL PHARMS LLC


Approval Date: 04/21/2022
Drug Name: GLYCOPYRROLATENDA #214919
Active Ingredients: GLYCOPYRROLATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FRESENIUS KABI USA


Approval Date: 04/22/2022
Drug Name: EPSOLAYNDA #214510
Active Ingredients: BENZOYL PEROXIDE
Submission Classification*:
Review Priority**: Standard
Company: SOL-GEL TECHNOLOGIES


Approval Date: 04/26/2022
Drug Name: VIVJOANDA #215888
Active Ingredients: OTESECONAZOLE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: MYCOVIA PHARMACEUTICALS INC


Approval Date: 04/28/2022
Drug Name: CAMZYOSNDA #214998
Active Ingredients: MAVACAMTEN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: MYOKARDIA INC


Approval Date: 04/28/2022
Drug Name: CUVRIORNDA #215760
Active Ingredients: TRIENTINE TETRAHYDROCHLORIDE
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: ORPHALAN SA

 

Upcoming Advisory Committee Meeting:

May 11th- May 12th : Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting- 10:00 AM- 3:30 PM ET (CDER)


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

 

USP: Supply chain experts tackle supply chain resiliency (published 01-Apr-2022)

Read Article on RAPS.org

Alzheimer’s disease: FDA guidance had ‘strong influence’ on endpoint selection (published 04-Apr-2022)

Read Article on RAPS.org

Califf lays out vision for connected healthcare ecosystem (published 04-Apr-2022)

Read Article on RAPS.org

FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more (published 04-Apr-2022)

Read Article on RAPS.org

Cavazzoni discusses CDER staffing, FY2023 budget priorities (published 05-Apr-2022)

Read Article on RAPS.org

Marks calls for new gene therapy development paradigm (published 05-Apr-2022)

Read Article on RAPS.org

ICH drafts guideline on pediatric extrapolation in drug development (published 06-Apr-2022)

Read Article on RAPS.org

FDA proposes framework for updated COVID vaccines to spur discussion (published 06-Apr-2022)

Read Article on RAPS.org

Unannounced FDA inspections have started in India, not China (published 07-Apr-2022)

Read Article on RAPS.org

FDA proposes to rate pharmaceutical manufacturing facilities (published 07-Apr-2022)

Read Article on RAPS.org

FDA finalizes guidance for hepatitis B drug development (published 11-Apr-2022)

Read Article on RAPS.org

FDA knocks Bausch for misleading promotion of psoriasis drug on Lifetime show (published 12-Apr-2022)

Read Article on RAPS.org

FDA finalizes two more safety and performance based pathway guidances (published 12-Apr-2022)

Read Article on RAPS.org

Two OTC manufacturers warned for inadequate investigations, lax testing and validation practices (published 12-Apr-2022)

Read Article on RAPS.org

FDA recommends sponsors plan to include race, ethnicity in clinical trial design (published 13-Apr-2022)

Read Article on RAPS.org

EMA, HTA consortium prep for HTA regulation coming into effect (published 14-Apr-2022)

Read Article on RAPS.org

House committee finds McKinsey overlapped contracts with FDA, opioid makers (published 14-Apr-2022)

Read Article on RAPS.org

FDA bioavailability guidance takes industry feedback into consideration (published 14-Apr-2022)

Read Article on RAPS.org

Celiac disease: FDA offers guidance on drug development (published 18-Apr-2022)

Read Article on RAPS.org

Industry guidance aims to help manufacturers adhere to bar coding requirements (published 18-Apr-2022)

Read Article on RAPS.org

FDA sends untitled letter to Illinois firm over unapproved stem cell treatments (published 19-Apr-2022)

Read Article on RAPS.org

Study: Extrapolation of drug indications from study populations by FDA is ‘common’ (published 19-Apr-2022)

Read Article on RAPS.org

Study: Black patients underrepresented in pivotal CAR T-cell trials (published 20-Apr-2022)

Read Article on RAPS.org

FDA proposes plan to mail back unused opioids (published 20-Apr-2022)

Read Article on RAPS.org

GAO highlights lack of policies to combat political interference at health agencies (published 25-Apr-2022)

Read Article on RAPS.org

FDA finalizes guidance for drugs and biologics containing nanomaterials (published 25-Apr-2022)

Read Article on RAPS.org

CHMP recommends four new medicines, including first-in-class treatment for follicular lymphoma (published 25-Apr-2022)

Read Article on RAPS.org

FDA officials: Firms with strong quality cultures more resilient to data integrity problems (published 26-Apr-2022)

Read Article on RAPS.org

European Commission outlines preparedness plan for COVID-19 management, future pandemics (published 27-Apr-2022)

Read Article on RAPS.org

FDA finalizes electronic postmarketing safety reporting guidance (published 27-Apr-2022)

Read Article on RAPS.org

FDA official discusses common deficiencies derailing ANDAs (published 27-Apr-2022)

Read Article on RAPS.org

Remote interactive evaluations: FDA official discusses lessons learned (published 29-Apr-2022)

Read Article on RAPS.org

 


 

Explore-More-Image-1