Regulatory Guidance Monthly Review - January 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 January 2023.

FDA Final Guidance:

Format and Content of a REMS Document Guidance for Industry (published 04-Jan-2023)
Download FDA Guidance

Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act (published 20-Jan-2023)
Download FDA Guidance

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry: Guidance for Industry (published 23-Jan-2023)
Download FDA Guidance

FDA Draft Guidance:

Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (published 12-Jan-2023)
Draft FDA Guidance

Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases: Draft Guidance for Industry; Availability (published 17-Jan-2023)
Draft FDA Guidance

Mpox: Development of Drugs and Biological Products; Guidance for Industry (published 19-Jan-2023)
Draft 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Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Draft Guidance for Industry (published 27-Jan-2023)
Draft FDA Guidance

Acromegaly: Developing Drugs for Treatment (published 30-Jan-2023)
Draft FDA Guidance

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms (published 31-Jan-2023)
Draft FDA Guidance

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (published 31-Jan-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 01/05/2023
Drug Name: CABAZITAXELNDA #208715
Active Ingredients: CABAZITAXEL
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SANDOZ INC

Approval Date: 01/06/2023
Drug Name: LEQEMBIBLA #761269
Active Ingredients: LECANEMAB-IRMB
Submission Classification*:
Review Priority**:
Company: EISAI INC

Approval Date: 01/10/2023
Drug Name: AIRSUPRANDA #214070
Active Ingredients: ALBUTEROL SULFATE; BUDESONIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: BOND

Approval Date: 01/13/2023
Drug Name: RYKINDONDA #212849
Active Ingredients: RISPERIDONE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SHANDONG LUYE

Approval Date: 01/19/2023
Drug Name: DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDENDA #214544
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: LUPIN LTD

Approval Date: 01/20/2023
Drug Name: VANCOMYCIN HYDROCHLORIDENDA #210274
Active Ingredients: VANCOMYCIN HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ZHEJAING NOVUS PHARMACEUTICALS CO. LTD

Approval Date: 01/20/2023
Drug Name: BRENZAVVYNDA #214373
Active Ingredients: BEXAGLIFLOZIN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: THERAXOSBIO LLC

Approval Date: 01/27/2023
Drug Name: JAYPIRCANDA #216059
Active Ingredients: PIRTOBRUTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: LOXO ONCOLOGY INC

Approval Date: 01/27/2023
Drug Name: ORSERDUNDA #217639
Active Ingredients: ELACESTRANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: STEMLINE THERAPEUTICS INC

Approval Date: 01/30/2023
Drug Name: TECHNETIUM TC-99M MERTIATIDE KITNDA #216820
Active Ingredients: TECHNETIUM TC-99M MERTIATIDE KIT
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: JUBILANT DRAXIMAGE

Approval Date: 01/30/2023
Drug Name: DAPTOMYCINNDA #217415
Active Ingredients: DAPTOMYCIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: XELLIA PHARMS APS

Upcoming Advisory Board Meetings

September 7, 2022 @ 12pm EDT- 6:30pm EDT: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee

September 22, 2022 @ 8:30am EDT- 5:00pm EDT: Vaccines and Related Biological Products Advisory Committee

September 22-23, 2022 @ 9:00am EDT to 1:15pm EDT : Meeting of the Oncologic Drugs Advisory Committee

ICH releases draft guideline proposing harmonized bioequivalence testing (published 03-Jan-2023)
Read Article on RAPS.org

FDA finalizes guidance on REMS format and content (published 04-Jan-2023)
Read Article on RAPS.org

Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules (published 05-Jan-2023)
Read Article on RAPS.org

CDER approved 37 novel drugs in 2022, its lowest number since 2016 (published 05-Jan-2023)
Read Article on RAPS.org

Provider groups, researchers raise concerns about extrapolating adult data in children (published 05-Jan-2023)
Read Article on RAPS.org

Drugmakers, and advocacy groups ask FDA to clarify expanded access draft guidance (published 06-Jan-2023)
Read Article on RAPS.org

Industry calls for flexibility in FDA’s pediatric measurement guidance (published 09-Jan-2023)
Read Article on RAPS.org

Califf, past FDA chiefs look for partners to curb misinformation (published 09-Jan-2023)
Read Article on RAPS.org

CDER director calls for simplifying clinical trials to boost diversity (published 10-Jan-2023)
Read Article on RAPS.org

A closer look at CDER’s novel drug approvals in 2022 (published 11-Jan-2023)
Read Article on RAPS.org

CERSI Summit: Wider use of real-world evidence continues to face hurdles (published 11-Jan-2023)
Read Article on RAPS.org

Omnibus brings new advanced manufacturing programs to FDA (published 11-Jan-2023)
Read Article on RAPS.org

FDA cites Sun Pharma with litany of GMP violations, including poor aseptic practices (published 11-Jan-2023)
Read Article on RAPS.org

Omnibus spending bill expands FDA’s unannounced foreign inspections pilot (published 12-Jan-2023)
Read Article on RAPS.org

FDA issues draft guidance on dosage and administration labeling (published 13-Jan-2023)
Read Article on RAPS.org

FDA official says pandemic reauthorization bill could drive VALID across finish line (published 13-Jan-2023)
Read Article on RAPS.org

Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics (published 16-Jan-2023)
Read Article on RAPS.org

FDA details approach for finding optimal dosages for new cancer drugs (published 17-Jan-2023)
Read Article on RAPS.org

Pharma groups say ICH guideline on viral safety evaluation needs to incorporate continuous manufacturing (published 19-Jan-2023)
Read Article on RAPS.org

FDA issues draft guidance on mpox drug development (published 19-Jan-2023)
Read Article on RAPS.org

FDA finalizes guidance on cannabis clinical research (published 23-Jan-2023)
Read Article on RAPS.org

Califf: Current evidence generation system in clinical research needs an overhaul (published 24-Jan-2023)
Read Article on RAPS.org

FDA to stay the course on orphan exclusivity post-Catalyst (published 24-Jan-2023)
Read Article on RAPS.org

ICH adopts Q9 guidelines on quality risk management (published 26-Jan-2023)
Read Article on RAPS.org

FDA announces FY 2023-2027 BsUFA science and research priorities (published 26-Jan-2023)
Read Article on RAPS.org

Vaccine adcomm recommends harmonizing COVID-19 shots (published 26-Jan-2023)
Read Article on RAPS.org

FDA proposes easing blood donor requirements (published 27-Jan-2023)
Read Article on RAPS.org

FDA to resume in-person formal meetings in February (published 30-Jan-2023)
Read Article on RAPS.org

FDA issues draft guidance on developing drugs for acromegaly (published 31-Jan-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