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Advancing Oncology Therapies for Patients in Need
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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.
New FDA Guidance Documents:
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (published 07-Apr-2022)
E8(R1) General Considerations for Clinical Studies (published 08-Apr-2022)
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (published 11-Apr-2022)
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (published 15-Apr-2022)
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (published 21-Apr-2022)
Providing Submissions in Electronic Format — Postmarketing Safety Reports (published 27-Apr-2022)
Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry (published 29-Apr-2022)
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (published 29-Apr-2022)
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)
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)
New Draft Guidance Documents: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ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES: Draft Guidance for Industry (published 06-Apr-2022)
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Draft Guidance for Industry (published 07-Apr-2022)
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Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability: Draft Guidance for Industry (published 13-Apr-2022)
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet (published 15-Apr-2022)
Ulcerative Colitis: Developing Drugs for Treatment (published 28-Apr-2022)
Crohn’s Disease: Developing Drugs for Treatment (published 28-Apr-2022)
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)
USP: Supply chain experts tackle supply chain resiliency (published 01-Apr-2022)
Alzheimer’s disease: FDA guidance had ‘strong influence’ on endpoint selection (published 04-Apr-2022)
Califf lays out vision for connected healthcare ecosystem (published 04-Apr-2022)
FDA’s legislative wish list includes device cybersecurity, a generic exclusivity fix, and more (published 04-Apr-2022)
Cavazzoni discusses CDER staffing, FY2023 budget priorities (published 05-Apr-2022)
Marks calls for new gene therapy development paradigm (published 05-Apr-2022)
ICH drafts guideline on pediatric extrapolation in drug development (published 06-Apr-2022)
FDA proposes framework for updated COVID vaccines to spur discussion (published 06-Apr-2022)
Unannounced FDA inspections have started in India, not China (published 07-Apr-2022)
FDA proposes to rate pharmaceutical manufacturing facilities (published 07-Apr-2022)
FDA finalizes guidance for hepatitis B drug development (published 11-Apr-2022)
FDA knocks Bausch for misleading promotion of psoriasis drug on Lifetime show (published 12-Apr-2022)
FDA finalizes two more safety and performance based pathway guidances (published 12-Apr-2022)
Two OTC manufacturers warned for inadequate investigations, lax testing and validation practices (published 12-Apr-2022)
FDA recommends sponsors plan to include race, ethnicity in clinical trial design (published 13-Apr-2022)
EMA, HTA consortium prep for HTA regulation coming into effect (published 14-Apr-2022)
House committee finds McKinsey overlapped contracts with FDA, opioid makers (published 14-Apr-2022)
FDA bioavailability guidance takes industry feedback into consideration (published 14-Apr-2022)
Celiac disease: FDA offers guidance on drug development (published 18-Apr-2022)
Industry guidance aims to help manufacturers adhere to bar coding requirements (published 18-Apr-2022)
FDA sends untitled letter to Illinois firm over unapproved stem cell treatments (published 19-Apr-2022)
Study: Extrapolation of drug indications from study populations by FDA is ‘common’ (published 19-Apr-2022)
Study: Black patients underrepresented in pivotal CAR T-cell trials (published 20-Apr-2022)
FDA proposes plan to mail back unused opioids (published 20-Apr-2022)
GAO highlights lack of policies to combat political interference at health agencies (published 25-Apr-2022)
FDA finalizes guidance for drugs and biologics containing nanomaterials (published 25-Apr-2022)
CHMP recommends four new medicines, including first-in-class treatment for follicular lymphoma (published 25-Apr-2022)
FDA officials: Firms with strong quality cultures more resilient to data integrity problems (published 26-Apr-2022)
European Commission outlines preparedness plan for COVID-19 management, future pandemics (published 27-Apr-2022)
FDA finalizes electronic postmarketing safety reporting guidance (published 27-Apr-2022)
FDA official discusses common deficiencies derailing ANDAs (published 27-Apr-2022)
Remote interactive evaluations: FDA official discusses lessons learned (published 29-Apr-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 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