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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 2022.
New FDA Guidance Documents
Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff (published 06-May-2022)
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: Guidance for Industry (published 16-May-2022)
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (published 18-May-2022)
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for Industry (published 23-May-2022)
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Clinical/Medical (published 27-May-2022)
FDA Draft Guidance
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability (published 02-May-2022)
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies (published 04-May-2022)
Benefit-Risk Considerations for Product Quality Assessments (published 09-May-2022)
Risk Management Plans to Mitigate the Potential for Drug Shortages (published 19-May-2022)
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Draft Guidance for Industry (published 23-May-2022)
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Draft Guidance for Industry (published 23-May-2022)
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1) (published 24-May-2022)
Monthly FDA Approvals
Approval Date: 05/02/2022
Drug Name: BORTEZOMIBNDA #209191
Active Ingredients: BORTEZOMIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HOSPIRA INC
Approval Date: 05/03/2022
Drug Name: VOQUEZNA TRIPLE PACKNDA #215152
Active Ingredients: AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Priority
Company: PHATHOM
Approval Date: 05/03/2022
Drug Name: VOQUEZNA DUAL PACKNDA #215153
Active Ingredients: AMOXICILLIN; VONOPRAZAN FUMARATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: PHATHOM
Approval Date: 05/12/2022
Drug Name: RADICAVA ORSNDA #215446
Active Ingredients: EDARAVONE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: MITSUBISHI TANABE
Approval Date: 05/13/2022
Drug Name: MOUNJARONDA #215866
Active Ingredients: TIRZEPATIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ELI LILLY AND CO
Approval Date: 05/16/2022
Drug Name: CARMUSTINENDA #215000
Active Ingredients: CARMUSTINE
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: ACCORD HLTHCARE
Approval Date: 05/17/2022
Drug Name: PEMETREXEDNDA #214408
Active Ingredients: PEMETREXED
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ACCORD HLTHCARE INC
Approval Date: 05/18/2022
Drug Name: TPOXXNDA #214518
Active Ingredients: TECOVIRIMAT
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SIGA TECHNOLOGIES
Approval Date: 05/23/2022
Drug Name: TYVASO DPINDA #214324
Active Ingredients: TREPROSTINIL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: UNITED THERAP
Approval Date: 05/23/2022
Drug Name: VTAMANDA #215272
Active Ingredients: TAPINAROF
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: DERMAVANT SCIENCES INC
Approval Date: 05/26/2022
Drug Name: PemetrexedNDA #214657
Active Ingredients: Pemetrexed
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SANDOZ INC
Approval Date: 05/26/2022
Drug Name: FYLNETRABLA #761084
Active Ingredients: PEGFILGRASTIM-PBBK
Submission Classification*:
Review Priority**:
Company: KASHIV BIOSCIENCES LLC
Upcoming Advisory Committee Meetings
June 7,2022: Vaccines and Related Biological Products Advisory Committee
June 8, 2022: Meeting of the Pharmacy Compounding Advisory Committee
June 9,2022: Cellular, Tissue, and Gene Therapies Advisory Committee
June 14, 2022: Vaccines and Related Biological Products Advisory Committee
June 17, 2022: Meeting of the Psychopharmacologic Drugs Advisory Committee
June 28, 2022: Vaccines and Related Biological Products Advisory Committee
June 29, 2022: Cellular, Tissue, and Gene Therapies Advisory Committee
FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease (published 02-May-2022)
FDA’s Office of Compliance details enforcement actions in 2021 (published 02-May-2022)
FDA's use of adcomms prior to drug approval decreased over the last decade (published 03-May-2022)
FDA officials: ‘New normal’ may include annual COVID vaccination (published 03-May-2022)
Commission proposes European Health Data Space to unlock research opportunities (published 04-May-2022)
ICH plans model-informed drug development guideline in 3-4 years (published 04-May-2022)
First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing (published 04-May-2022)
Pharmaceutical industry groups suggest ICH Q9 changes (published 06-May-2022)
FDA sheds light on conducting human radiolabeled mass balance studies (published 10-May-2022)
Changes to pediatric, orphan drug regulations on European horizon (published 11-May-2022)
FDA offers insight into product quality assessment principles (published 11-May-2022)
Pandemic highlighted challenges of ATMP clinical trials in Europe (published 12-May-2022)
FDA works to advance real-world data collection in pregnancy and lactation (published 16-May-2022)
Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints (published 17-May-2022)
FDA, EMA officials discuss impediments to cell and gene therapies (published 17-May-2022)
FDA updates guidance on evaluating out-of-specification results for drugs (published 18-May-2022)
New report urges more clinical trial diversity, recommends incentives (published 18-May-2022)
FDA explains plans to bolster cell and gene therapy approvals through wider messaging (published 19-May-2022)
FDA asks manufacturers to develop risk management plans to avert shortages (published 20-May-2022)
Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation (published 23-May-2022)
FDA takes steps to relax blood donor requirements (published 23-May-2022)
EMA releases final guideline on antibacterial drug development (published 24-May-2022)
House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections (published 25-May-2022)
FDA officials reflect on quality maturity model, quality metrics (published 27-May-2022)
Study: Breakthrough designated drugs led to better clinical outcomes for patients with NSCLC (published 31-May-2022)
FDA and EMA mostly align on GCP inspection deficiencies, study finds (published 31-May-2022)
New diagnostics authorities, accelerated approval council featured in Senate user fee bill (published 31-May-2022)
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Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
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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