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Advancing Oncology Therapies for Patients in Need
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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 September 2022.
New FDA Guidance Documents
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products (published 09-Sep-2022)
Q3D(R2) – Guideline for Elemental Impurities: International Council for Harmonisation; Draft Guidance for Industry (published 14-Sep-2022)
Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (published 28-Sep-2022)
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (published 28-Sep-2022)
FDA Draft Guidance
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products (published 07-Sep-2022)
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products (published 08-Sep-2022)
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (published 08-Sep-2022)
How To Obtain a Covered Product Authorization (published 21-Sep-2022)
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs (published 26-Sep-2022)
Monthly FDA Approvals
Approval Date: 09/01/2022
Drug Name: STIMUFENDBLA #761173
Active Ingredients: PEGFILGRASTIM-FPGK
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA
Approval Date: 09/01/2022
Drug Name: SPEVIGOBLA #761244
Active Ingredients: SPESOLIMAB-SBZO
Submission Classification*:
Review Priority**:
Company: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Approval Date: 09/07/2022
Drug Name: DAXXIFYBLA #761127
Active Ingredients: DAXIBOTULINUMTOXINA-LANM
Submission Classification*:
Review Priority**:
Company: REVANCE THERAPEUTICS, INC.
Approval Date: 09/09/2022
Drug Name: SOTYKTUNDA #214958
Active Ingredients: DEUCRAVACITINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BRISTOL
Approval Date: 09/09/2022
Drug Name: ROLVEDONBLA #761148
Active Ingredients: EFLAPEGRASTIM-XNST
Submission Classification*:
Review Priority**:
Company: SPECTRUM PHARMS
Approval Date: 09/14/2022
Drug Name: TERLIVAZNDA #022231
Active Ingredients: TERLIPRESSIN ACETATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: MALLINCKRODT IRELAND
Approval Date: 09/15/2022
Drug Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDENDA #215700
Active Ingredients: NOREPINEPHRINE BITARTRATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: INFORLIFE
Approval Date: 09/16/2022
Drug Name: APONVIENDA #216457
Active Ingredients: APREPITANT
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Standard
Company: HERON THERAPS INC
Approval Date: 09/20/2022
Drug Name: PEDMARKNDA #212937
Active Ingredients: SODIUM THIOSULFATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: FENNEC PHARMACEUTICALS INC
Approval Date: 09/22/2022
Drug Name: OMLONTINDA #215092
Active Ingredients: OMIDENEPAG ISOPROPYL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: SANTEN
Approval Date: 09/27/2022
Drug Name: IHEEZONDA #216227
Active Ingredients: CHLOROPROCAINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SINTETICA SA
Approval Date: 09/27/2022
Drug Name: VEGZELMABLA #761268
Active Ingredients: BEVACIZUMAB-ADCD
Submission Classification*:
Review Priority**:
Company: CELLTRION
Approval Date: 09/29/2022
Drug Name: RELYVRIONDA #216660
Active Ingredients: SODIUM PHENYLBUTYRATE; SODIUM TAURURSODIOL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: AMYLYX PHARMS
Approval Date: 09/30/2022
Drug Name: LYTGOBINDA #214801
Active Ingredients: FUTIBATINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: TAIHO ONCOLOGY
Upcoming Advisory Committee Meetings
10/06/2022- Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting Announcement
10/26/2022- Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
10/28/2022- Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
10/31/2022- Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
How to learn about healthcare product labeling and why it matters for regulatory professionals (published 02-Sep-2022)
Clinical trials: Real-world data plays early role in efforts to increase diversity (published 05-Sep-2022)
Industry experts tout potential for master protocols in pediatric clinical trials (published 07-Sep-2022)
FDA drafts guidance on pediatric clinical pharmacology studies (published 08-Sep-2022)
FDA issues emergency guidance to spur development of monkeypox tests (published 09-Sep-2022)
EMA officials discuss avenues for ATMP development at Convergence 2022 (published 12-Sep-2022)
FDA issues guidance documents on labeling drug identity, constituents (published 13-Sep-2022)
FDA finalizes guidance on submitting RWD/RWE in application cover letters (published 13-Sep-2022)
Nearly one in five regulatory professionals changed jobs in 2021, new report shows (published 13-Sep-2022)
Convergence: Upfront planning, communication critical to ensuring success in real-time oncology reviews (published 13-Sep-2022)
Convergence: EU official says no delay to CTIS implementation, despite industry concerns (published 15-Sep-2022)
Convergence: Understanding expedited approval pathways in Japan (published 19-Sep-2022)
CHMP recommends 12 new medicines, including first RSV treatment for infants (published 19-Sep-2022)
CDER official reflects on a decade of patient-focused drug development (published 19-Sep-2022)
Convergence: Global landscape evolves on real-world evidence, but at an uneven pace (published 20-Sep-2022)
Califf: FDA committed to boosting complex generic drug development (published 20-Sep-2022)
Industry seeks clarity on FDA’s standards recognition process for regenerative medicines (published 21-Sep-2022)
EMA proposes quality guidelines for synthetic peptides and oligonucleotides (published 22-Sep-2022)
FDA officials urge ‘comprehensive’ approach to accelerated approval reforms (published 22-Sep-2022)
FDA plans to study medication adherence claims, endorser effect in DTC advertising (published 22-Sep-2022)
Convergence: RWE regulatory successes offer lessons for US applications (published 23-Sep-2022)
New FDA guidance offers ethical roadmap for including children in clinical trials (published 26-Sep-2022)
Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies (published 27-Sep-2022)
FDA seek to harmonize human subject protections with revised Common Rule (published 27-Sep-2022)
FDA elevates OTAT to “Super Office” within CBER (published 30-Sep-2022)
OIG raises concerns about accelerated approval pathway (published 30-Sep-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