Regulatory Guidance Monthly Review - May 2022

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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.

 

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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)

Download FDA Guidance

 

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision:  Guidance for Industry (published 16-May-2022)

Download FDA Guidance

 

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (published 18-May-2022)

Download FDA Guidance

 

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)

Download FDA Guidance

 

Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry:  Clinical/Medical (published 27-May-2022)

Download FDA Guidance

 

FDA Draft Guidance

 

 

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability (published 02-May-2022)

Draft FDA Guidance

 

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies (published 04-May-2022)

Draft FDA Guidance

 

Benefit-Risk Considerations for Product Quality Assessments (published 09-May-2022)

Draft FDA Guidance

 

Risk Management Plans to Mitigate the Potential for Drug Shortages (published 19-May-2022)

Draft FDA Guidance

 

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Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Draft Guidance for Industry (published 23-May-2022)

Draft FDA Guidance

 

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Draft Guidance for Industry (published 23-May-2022)

Draft FDA Guidance

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)

Draft FDA Guidance

 

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


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease (published 02-May-2022)

Read Article on RAPS.org

FDA’s Office of Compliance details enforcement actions in 2021 (published 02-May-2022)

Read Article on RAPS.org

FDA's use of adcomms prior to drug approval decreased over the last decade (published 03-May-2022)

Read Article on RAPS.org

FDA officials: ‘New normal’ may include annual COVID vaccination (published 03-May-2022)

Read Article on RAPS.org

Commission proposes European Health Data Space to unlock research opportunities (published 04-May-2022)

Read Article on RAPS.org

ICH plans model-informed drug development guideline in 3-4 years (published 04-May-2022)

Read Article on RAPS.org

First in vitro diagnostic for early Alzheimer’s detection gets FDA blessing (published 04-May-2022)

Read Article on RAPS.org

Pharmaceutical industry groups suggest ICH Q9 changes (published 06-May-2022)

Read Article on RAPS.org

FDA sheds light on conducting human radiolabeled mass balance studies (published 10-May-2022)

Read Article on RAPS.org

Changes to pediatric, orphan drug regulations on European horizon (published 11-May-2022)

Read Article on RAPS.org

FDA offers insight into product quality assessment principles (published 11-May-2022)

Read Article on RAPS.org

Pandemic highlighted challenges of ATMP clinical trials in Europe (published 12-May-2022)

Read Article on RAPS.org

FDA works to advance real-world data collection in pregnancy and lactation (published 16-May-2022)

Read Article on RAPS.org

Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints (published 17-May-2022)

Read Article on RAPS.org

FDA, EMA officials discuss impediments to cell and gene therapies (published 17-May-2022)

Read Article on RAPS.org

FDA updates guidance on evaluating out-of-specification results for drugs (published 18-May-2022)

Read Article on RAPS.org

New report urges more clinical trial diversity, recommends incentives (published 18-May-2022)

Read Article on RAPS.org

FDA explains plans to bolster cell and gene therapy approvals through wider messaging (published 19-May-2022)

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FDA asks manufacturers to develop risk management plans to avert shortages (published 20-May-2022)

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Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation (published 23-May-2022)

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FDA takes steps to relax blood donor requirements (published 23-May-2022)

Read Article on RAPS.org

EMA releases final guideline on antibacterial drug development (published 24-May-2022)

Read Article on RAPS.org

House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections (published 25-May-2022)

Read Article on RAPS.org

FDA officials reflect on quality maturity model, quality metrics (published 27-May-2022)

Read Article on RAPS.org

Study: Breakthrough designated drugs led to better clinical outcomes for patients with NSCLC (published 31-May-2022)

Read Article on RAPS.org

FDA and EMA mostly align on GCP inspection deficiencies, study finds (published 31-May-2022)

Read Article on RAPS.org

New diagnostics authorities, accelerated approval council featured in Senate user fee bill (published 31-May-2022)

Read Article on RAPS.org

 


 

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