Regulatory Guidance Monthly Review - June 2023

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 June 2023.

FDA Final Guidance

Cover Letter Attachments for Controlled Correspondences and ANDA Submissions (published 05-Jun-2023)
Download FDA Guidance

Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals (published 05-Jun-2023)
Download FDA Guidance

Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry (published 08-Jun-2023)
Download FDA Guidance

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (published 20-Jun-2023)
Download FDA Guidance

Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry (published 22-Jun-2023)
Download FDA Guidance

Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical (published 23-Jun-2023)
Download FDA Guidance

Presenting Quantitative Efficacy and Risk Information in Direct- to-Consumer (DTC) Promotional Labeling and Advertisements (published 27-Jun-2023)
Download FDA Guidance

Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment (published 29-Jun-2023)
Download FDA Guidance

FDA Draft Guidance:

Migraine: Developing Drugs for Preventive Treatment (published 01-Jun-2023)
Draft FDA Guidance

Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment (published 05-Jun-2023)
Draft FDA Guidance

E6(R3) GOOD CLINICAL PRACTICE (GCP) (published 08-Jun-2023)
Draft FDA Guidance

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act (published 23-Jun-2023)
Draft FDA Guidance

Psychedelic Drugs: Considerations for Clinical Investigations (published 26-Jun-2023)
Draft FDA Guidance 

Monthly FDA Approvals

Approval Date: 45084
Drug Name: CYCLOPHOSPHAMIDENDA #210852
Active Ingredients: CYCLOPHOSPHAMIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: DR REDDYS

Approval Date: 45092
Drug Name: SUFLAVENDA #215344
Active Ingredients: MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: BRAINTREE LABS

Approval Date: 45092
Drug Name: COLUMVIBLA #761309
Active Ingredients: GLOFITAMAB-GXBM
Submission Classification*:
Review Priority**:
Company: GENENTECH INC

Approval Date: 45093
Drug Name: LODOCONDA #215727
Active Ingredients: COLCHICINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: AGEPHAPHARMAFZ LLC

Approval Date: 45097
Drug Name: VYVGART HYTRULOBLA #761304
Active Ingredients: EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
Submission Classification*:
Review Priority**:
Company: ARGENX BV

Approval Date: 45100
Drug Name: LITFULONDA #215830
Active Ingredients: RITLECITINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: PFIZER INC

Approval Date: 45103
Drug Name: RYSTIGGOBLA #761286
Active Ingredients: ROZANOLIXIZUMAB-NOLI
Submission Classification*:
Review Priority**:
Company: UCB INC

Approval Date: 45104
Drug Name: NGENLABLA #761184
Active Ingredients: SOMATROGON-GHLA
Submission Classification*:
Review Priority**:
Company: PFIZER IRELAND PHARMACEUTICALS

Upcoming Advisory Board Meetings

No upcoming meetings in July

Accelerated approval trials: Commenters seek details on single-arm considerations (published 01-Jun-2023)
Read Article on RAPS.org

FDA issues draft guidance on developing migraine prevention drugs (published 01-Jun-2023)
Read Article on RAPS.org

FDA finalizes drug-drug interaction guidance for therapeutic proteins (published 02-Jun-2023)
Read Article on RAPS.org

FDA officials tout steady growth in biosimilar program, enhancements under FDORA (published 05-Jun-2023)
Read Article on RAPS.org

FDA seeks feedback on ICH E6(R3) GCP guideline (published 06-Jun-2023)
Read Article on RAPS.org

FDA officials: ‘Significant work’ still needed for rare disease drug development (published 06-Jun-2023)
Read Article on RAPS.org

Manufacturers seek clarity on FDA’s drug shortage notification guidance (published 07-Jun-2023)
Read Article on RAPS.org

FDA saw uptick in drug shortages in 2022 (published 08-Jun-2023)
Read Article on RAPS.org

FDA officials say high priority will be given to applications with endpoints that can be leveraged for other rare diseases (published 09-Jun-2023)
Read Article on RAPS.org

Experts: FDA has legal authority to require greater postmarket safeguards (published 09-Jun-2023)
Read Article on RAPS.org

FDA and industry assert that user fee pilot programs have been successful in expediting product approvals (published 12-Jun-2023)
Read Article on RAPS.org

ICH charts new topics, touts progress in updating existing guidelines (published 20-Jun-2023)
Read Article on RAPS.org

FDA pilot aims to boost transparency for oncology tests (published 20-Jun-2023)
Read Article on RAPS.org

Pharmacogenomic data guidance: Industry objects to reporting exploratory studies (published 21-Jun-2023)
Read Article on RAPS.org

FDA’s drug quality report card details enforcement trends, increased inspections in 2022 (published 21-Jun-2023)
Read Article on RAPS.org

RWD supports regulatory decisions in Europe, but more sources are needed (published 26-Jun-2023)
Read Article on RAPS.org

DIA: Marks rejects ‘cookie cutter’ approach to rare disease reviews (published 27-Jun-2023)
Read Article on RAPS.org

FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional labeling, ads (published 28-Jun-2023)
Read Article on RAPS.org

FDA issues first psychedelic drug trial guidance (published 28-Jun-2023)
Read Article on RAPS.org

Expert: High costs, complexity are headwinds for growing clinical trials sector (published 29-Jun-2023)
Read Article on RAPS.org

• Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
• 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