Regulatory Guidance Monthly Review - February 2024

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 February 2024.

FDA Final Guidance

Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (published 05-Feb-2024)
Download FDA Guidance

Charging for Investigational Drugs Under an IND: Questions and Answers (published 14-Feb-2024)
Download FDA Guidance

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (published 22-Feb-2024)
Download FDA Guidance

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide (published 26-Feb-2024)
Download FDA Guidance

FDA Draft Guidance:

Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act (published 06-Feb-2024)
Draft FDA Guidance

Advanced Manufacturing Technologies Designation Program (12-Feb-2024)
Draft FDA Guidance

Use of Data Monitoring Committees in Clinical Trials (13-Feb-2024)
Draft FDA Guidance

Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (29-Feb-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 45309
Drug Name: DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDENDA #212427
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: HETERO LABS LTD III

Approval Date: 02/09/2024
Drug Name: EOHILIANDA #213976
Active Ingredients: BUDESONIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: TAKEDA PHARMS USA

Approval Date: 02/13/2024
Drug Name: LEGUBETINDA #215040
Active Ingredients: ACETYLCYSTEINE LYSINE
Submission Classification*: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Review Priority**: Standard
Company: GALEPHAR

Approval Date: 02/13/2024
Drug Name: AURLUMYNNDA #217933
Active Ingredients: ILOPROST
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: EICOS SCI

Approval Date: 02/14/2024
Drug Name: PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDENDA #217512
Active Ingredients: PANTOPRAZOLE SODIUM
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: BAXTER HLTHCARE CORP

Approval Date: 02/16/2024
Drug Name: SEHIPPYNDA #218328
Active Ingredients: VORTIOXETINE
Submission Classification*: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Review Priority**: Standard
Company: SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD

Approval Date: 02/22/2024
Drug Name: EXBLIFEPNDA #216165
Active Ingredients: CEFEPIME;ENMETAZOBACTAM
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Priority
Company: ALLECRA THERAPEUTICS SAS

Approval Date: 02/23/2024
Drug Name: SIMLANDIBLA #761299
Active Ingredients: ADALIMUMAB-RYVK
Submission Classification*:
Review Priority**:
Company: ALVOTECH USA INC

Approval Date: 02/29/2024
Drug Name: LETYBOBLA #761225
Active Ingredients: LETIBOTULINUMTOXINA-WLBG
Submission Classification*:
Review Priority**:
Company: HUGEL INC

Upcoming Advisory Board Meetings

03/05/2024- Meeting of the Medical Imaging Drug Advisory Committee Meeting- 09:00 AM EDT to 5:30 PM EDT

03/14/2024- Meeting of the Oncologic Advisory Meeting- 9:30 AM EDT to 3:00 PM EDT

03/15/2024- Meeting of the Oncologic Advisory Meeting- 8:30 AM EDT to 5:30 PM EDT

05/16/2024- Vaccines and Related Biological Products Advisory Committee Meeting 8:30 AM EDT to 4:30 PM EDT

Califf says major effort underway to reform advisory committee meetings (published 01-Feb-2024)
Read Article on RAPS.org

EMA proposes waiving comparative efficacy studies for certain biosimilars (published 02-Feb-2024)
Read Article on RAPS.org

FDA officials say different communication methods needed to ensure AI/ML transparency (published 02-Feb-2024)
Read Article on RAPS.org

FDA officials: Transforming evidence generation to tackle chronic diseases (published 05-Feb-2024)
Read Article on RAPS.org

FDA gives drugmakers 3 weeks to begin reporting supply chain data (published 05-Feb-2024)
Read Article on RAPS.org

Official: FDA modernizing pharmacovigilance oversight with AI tools (published 06-Feb-2024)
Read Article on RAPS.org

FDA finalizes best practices guide for postmarketing safety studies (published 06-Feb-2024)
Read Article on RAPS.org

Lawmakers voice concerns over FDA’s foreign inspection program (published 06-Feb-2024)
Read Article on RAPS.org

Impurities management in drug products: A simulated case study (published 07-Feb-2024)
Read Article on RAPS.org

FDA issues new draft guidance on data monitoring committees (published 12-Feb-2024)
Read Article on RAPS.org

FDA, EMA officials say diverse pharmacovigilance strategies, long-term follow-up needed for ATMPs (published 13-Feb-2024)
Read Article on RAPS.org

FDA finalizes guidance on charging for investigational drugs (published 14-Feb-2024)
Read Article on RAPS.org

FDA misses congressional deadline to update clinical trial diversity guidance (published 15-Feb-2024)
Read Article on RAPS.org

FDA officials discuss REMS transparency efforts (published 15-Feb-2024)
Read Article on RAPS.org

Califf: New systems needed for bringing rare disease treatments, at-home devices to market (published 15-Feb-2024)
Read Article on RAPS.org

ICH consults on revised post-approval safety guideline that accounts for digital platforms (published 16-Feb-2024)
Read Article on RAPS.org

EMA proposes new guideline on non-inferiority trials (published 19-Feb-2024)
Read Article on RAPS.org

FDA warns industry about potential data integrity issues with third-party labs (published 20-Feb-2024)
Read Article on RAPS.org

Mark McClellan: More alignment needed on RWD terminology (published 21-Feb-2024)
Read Article on RAPS.org

ICH targets cell and gene therapies, real-world data as topics ripe for harmonization (published 23-Feb-2024)
Read Article on RAPS.org

Marks talks OTP staffing, gene therapies, and more (published 27-Feb-2024)
Read Article on RAPS.org

FDA finalizes guidance on designing pharmacology studies for antibody-drug conjugates (published 29-Feb-2024)
Read Article on RAPS.org

• Review the recording from our webinar: Future Trends on Europeans Regulations on Medicines
• Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
• Read our infographic to learn more about the different types of meetings under BsUFA FDA Meeting Types for Biosimilar Products
• Download the Infographic explaining the Types of FDA Meetings with CDER and CBER