Regulatory Guidance Monthly Review - May 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 May 2023.

FDA Final Guidance

S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
(published 01-May-2023)
Download FDA Guidance

Q9(R1) Quality Risk Management (published 03-May-2023)
Download FDA Guidance

Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol (published 08-May-2023)
Download FDA Guidance

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (published 11-May-2023)
Download FDA Guidance

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components (published 11-May-2023)
Download FDA Guidance

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers (published 24-May-2023)
Download FDA Guidance

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (published 26-May-2023)
Download FDA Guidance

FDA Draft Guidance:

Decentralized Clinical Trials for Drugs, Biological Products, and Devices (published 03-May-2023)
Draft FDA Guidance

Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act (published 17-May-2023)
Draft FDA Guidance

Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations (published 17-May-2023)
Draft FDA Guidance

Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information (published 24-May-2023)
Draft FDA Guidance

Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products (published 25-May-2023) 19-Apr-2023)
Draft FDA Guidance 

Monthly FDA Approvals

Approval Date: 05/01/2023
Drug Name: LUMRYZNDA #214755
Active Ingredients: SODIUM OXYBATE
Submission Classification*:
Review Priority**: Standard
Company: AVADEL CNS

Approval Date: 05/04/2023
Drug Name: MOTPOLY XRNDA #216185
Active Ingredients: LACOSAMIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AUCTA

Approval Date: 05/05/2023
Drug Name: MYDCOMBINDA #215352
Active Ingredients: PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: EYENOVIA

Approval Date: 05/08/2023
Drug Name: CEFAZOLIN SODIUMNDA #211413
Active Ingredients: CEFAZOLIN SODIUM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HQ SPCLT PHARMA

Approval Date: 05/09/2023
Drug Name: ZOLPIDEM TARTRATENDA #215721
Active Ingredients: ZOLPIDEM TARTRATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ALMATICA

Approval Date: 05/09/2023
Drug Name: ELFABRIOBLA #761161
Active Ingredients: PEGUNIGALSIDASE ALFA-IWXJ
Submission Classification*:
Review Priority**:
Company: CHIESI FARMACEUTICI SPA

Approval Date: 05/11/2023
Drug Name: PACLITAXELNDA #216338
Active Ingredients: PACLITAXEL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: TEVA PHARMS INC

Approval Date: 05/12/2023
Drug Name: VEOZAHNDA #216578
Active Ingredients: FEZOLINETANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ASTELLAS

Approval Date: 05/18/2023
Drug Name: PHYRAGONDA #216099
Active Ingredients: DASATINIB
Submission Classification*:
Review Priority**: Standard
Company: NANOCOPOEIA LLC

Approval Date: 05/18/2023
Drug Name: MIEBONDA #216675
Active Ingredients: PERFLUOROHEXYLOCTANE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BAUSCH AND LOMB INC

Approval Date: 05/19/2023
Drug Name: EPKINLYBLA #761324
Active Ingredients: EPCORITAMAB-BYSP
Submission Classification*:
Review Priority**:
Company: GENMAB US, INC.

Approval Date: 05/22/2023
Drug Name: PEMETREXEDNDA #215179
Active Ingredients: PEMETREXED
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SHILPA MEDICARE LTD

Approval Date: 05/22/2023
Drug Name: OPVEENDA #217470
Active Ingredients: NALMEFENE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: OPIANT PHARMACEUTICALS INC

Approval Date: 05/23/2023
Drug Name: BRIXADINDA #210136
Active Ingredients: BUPRENORPHINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: BRAEBURN PHARMA INC

Approval Date: 05/23/2023
Drug Name: XACDURONDA #216974
Active Ingredients: SULBACTAM;DURLOBACTAM
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Priority
Company: ENTASIS THERAPEUTICS INC

Approval Date: 05/23/2023
Drug Name: YUFLYMABLA #761219
Active Ingredients: ADALIMUMAB-AATY
Submission Classification*:
Review Priority**:
Company: CELLTRION

Approval Date: 05/25/2023
Drug Name: POSLUMANDA #216023
Active Ingredients: FLOTUFOLASTAT F-18
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BLUE EARTH DIAGNOSTICS LTD.

Approval Date: 05/25/2023
Drug Name: PAXLOVIDNDA #217188
Active Ingredients: RITONAVIR, NIRMATRELVIR
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: PFIZER INC

Approval Date: 05/26/2023
Drug Name: DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDENDA #215448
Active Ingredients: DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: AUROBINDO PHARMA USA

Approval Date: 05/26/2023
Drug Name: INPEFANDA #216203
Active Ingredients: SOTAGLIFLOZIN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: LEXICON PHARMACEUTICALS INC

Approval Date: 05/30/2023
Drug Name: VEVYENDA #217469
Active Ingredients: CYCLOSPORINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: NOVALIQ GMBH

Upcoming Advisory Board Meetings

06/08/2023 - Antimicrobial Drugs Advisory Committee Meeting- 09:30 AM EDT to 5:00 PM EDT

06/09/2023 - Peripheral and Central Nervous System Drugs Advisory Committee Meeting- 10:00 AM EDT to 05:00 PM EDT

06/15/2023 - Vaccines and Related Biological Products Advisory Committee Meeting- 08:30 AM EDT to 05:00 PM EDT

06/16/2023 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting- 10:00 AM EDT to 03:30 PM EDT

06/28/2023 - Endocrinologic Drugs Advisory Committee Meeting- 09:30 AM EDT to 05:30 PM EDT-

FDA issues draft guidance on decentralized clinical trials (published 02-May-2023)
Read Article on RAPS.org

Stakeholders want more clarity from FDA on using data from externally controlled trials (published 03-May-2023)
Read Article on RAPS.org

Study: Most oncology drugs approved in Japan based on surrogate endpoints do not undergo confirmatory trials (published 04-May-2023)
Read Article on RAPS.org

AI in drug manufacturing: Stakeholders call for harmonization, further guidance (published 09-May-2023)
Read Article on RAPS.org

Experts: Potential EU ban on titanium dioxide would threaten access to drugs (published 09-May-2023)
Read Article on RAPS.org

Regulators discuss concerns, sustainable GMP compliance at ISPE Europe (published 11-May-2023)
Read Article on RAPS.org

FDA final guidance relaxes criteria for blood donors (published 11-May-2023)
Read Article on RAPS.org

FDA publishes discussion paper on AI/ML in drug development (published 12-May-2023)
Read Article on RAPS.org

Commenters seek clarity in FDA draft guidance on electronic systems, signatures in clinical trials (published 18-May-2023)
Read Article on RAPS.org

Dual draft guidances outline FDA vision for pediatric drug development, exclusivity (published 19-May-2023)
Read Article on RAPS.org

FDA officials discuss RWE, don’t endorse a ‘checklist’ approach (published 22-May-2023)
Read Article on RAPS.org

EMA publishes 10-point guidance to address drug shortages (published 22-May-2023)
Read Article on RAPS.org

FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals (published 24-May-2023)
Read Article on RAPS.org

Stakeholders welcome FDA’s framework for DHTs in drug development, cite challenges with adoption (published 25-May-2023)
Read Article on RAPS.org

E6(R3): ICH releases draft of overhauled GCP guideline for consultation (published 25-May-2023)
Read Article on RAPS.org

FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies (published 26-May-2023)
Read Article on RAPS.org

FDA finalizes guidance on adjusting for covariates in randomized trials (published 30-May-2023)
Read Article on RAPS.org

FDA considers new efficacy endpoint for diabetes drugs (published 31-May-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