Regulatory Guidance Monthly Review - April 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 April 2023.

FDA Final Guidance

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers (12-Apr-2023)
Download FDA Guidance

FDA Draft Guidance:

Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (published 05-Apr-2023)
Draft FDA 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 05-Apr-2023)
Draft FDA Guidance

Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry (published 12-Apr-2023)
Draft FDA Guidance

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs (13-Apr-2023)
Draft FDA Guidance

Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment (published 19-Apr-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 04/14/2023
Drug Name: RIZAFILMNDA #205394
Active Ingredients: RIZATRIPTAN BENZOATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: INTELGENX CORP

Approval Date: 04/21/2023
Drug Name: EPINEPHRINE IN 0.9% SODIUM CHLORIDENDA #215875
Active Ingredients: EPINEPHRINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: PAR STERILE PRODUCTS

Approval Date: 04/25/2023
Drug Name: QALSODYNDA #215887
Active Ingredients: TOFERSEN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BIOGEN IDEC INC

Approval Date: 04/26/2023
Drug Name: ZEJULANDA #214876
Active Ingredients: NIRAPARIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: GLAXOSMITHKLINE LLC

Approval Date: 04/26/2023
Drug Name: TRIKAFTANDA #217660
Active Ingredients: ELEXACAFTOR;TEZACAFTOR;IVACAFTOR;IVACAFTOR
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: VERTEX PHARMS INC

Approval Date: 04/27/2023
Drug Name: ABILIFY ASIMTUFIINDA #217006
Active Ingredients: ARIPIPRAZOLE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: OTSUKA PHARM CO LTD

Approval Date: 04/28/2023
Drug Name: UZEDYNDA #213586
Active Ingredients: RISPERIDONE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: TEVA NEUROSCIENCE INC

Approval Date: 04/28/2023
Drug Name: LIQREVNDA #214952
Active Ingredients: SILDENAFIL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: CMP DEV LLC

Approval Date: 04/28/2023
Drug Name: DOLUTEGRAVIRNDA #215319
Active Ingredients: DOLUTEGRAVIR
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: LAURUS GENERICS INC

Approval Date: 04/28/2023
Drug Name: SYMBICORTNDA #216579
Active Ingredients: BUDESONIDE AND FORMOTEROL FUMARATE
Submission Classification*: Efficacy
Review Priority**: Standard
Company: ASTRAZENECA PHARMS LP

Upcoming Advisory Board Meetings

05/09/2023- 05/10/2023- Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee Meeting- 09:30 AM EDT to 1:30 PM EDT

05/11/2023- Pulmonary-Allergy Drugs Advisory Committee Meeting- 09:00 AM EDT to 05:00 PM EDT

05/12/2023- Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting- 09:00 AM EDT to 06:00 PM EDT

05/18/2023- Vaccines and Related Biological Products Advisory Committee Meeting- 08:30 AM EDT to 05:30 PM EDT

05/19/2023- Meeting of the Gastrointestinal Drugs Advisory Committee- 09:00 AM EDT to 05:00 PM EDT

FDA to require mail-back envelopes for unused opioids (published 03-Apr-2023))
Read Article on RAPS.org

Guidance details review process for pediatric research not approvable by an IRB (published 03-Apr-2023)
Read Article on RAPS.org

Study: Half of confirmatory studies for accelerated approvals are late (published 04-Apr-2023)
Read Article on RAPS.org

FDA issues last guidance in patient-focused drug development series (published 05-Apr-2023)
Read Article on RAPS.org

FDA withdraws pre-term birth drug Makena (published 06-Apr-2023)
Read Article on RAPS.org

CBER chief discusses hiring and retention challenges brought on by remote work (published 06-Apr-2023)
Read Article on RAPS.org

FDA updates guidance on reporting manufacturing disruptions for finished products and APIs (published 07-Apr-2023)
Read Article on RAPS.org

ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk (published 07-Apr-2023)
Read Article on RAPS.org

Commenters concerned about scope of FDA’s BsUFA regulatory science pilot (published 10-Apr-2023)
Read Article on RAPS.org

FDA outlines risk-based approach to monitoring clinical trials (published 11-Apr-2023)
Read Article on RAPS.org

Pragmatica: Lung cancer trial tests streamlined design, inclusive eligibility (published 12-Apr-2023)
Read Article on RAPS.org

ORA head says attrition is outpacing hiring, decries flat funding for inspections (published 17-Apr-2023)
Read Article on RAPS.org

FDA to require new safety warnings for opioids (published 17-Apr-2023)
Read Article on RAPS.org

Global regulators discuss how they are adapting to AI, real-world data in drug and food safety (published 18-Apr-2023)
Read Article on RAPS.org

FDA cites Lupin for lax oversight of equipment breakdowns, poor follow up and more (published 18-Apr-2023)
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FDA draft guidance aims to help sponsors develop drugs for radiation exposure (published 20-Apr-2023)
Read Article on RAPS.org

Califf seeks new authorities to approve opioids, mum on mifepristone (published 20-Apr-2023)
Read Article on RAPS.org

EMA addresses considerations for single-arm trials (published 21-Apr-2023)
Read Article on RAPS.org

FDA officials offer CMC advice for gene therapies at OTP town hall (published 25-Apr-2023)
Read Article on RAPS.org

EU releases draft legislation that will reshape pharma regulation (published 26-Apr-2023)
Read Article on RAPS.org

User fee hiring: CBER on track while CDER lags (published 27-Apr-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