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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 July 2022.
New FDA Guidance Documents
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format (published 15-Jul-2022)
Orange Book Questions and Answers Guidance for Industry: Guidance for Industry (published 22-Jul-2022)
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry (published 22-Jul-2022)
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings: Guidance for Industry (published 27-Jul-2022)
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry (published 27-Jul-2022)
FDA Draft Guidance
Identifying Trading Partners Under the Drug Supply Chain Security Act (published 05-Jul-2022)
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry (published 06-Jul-2022)
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” (published 21-Jul-2022)
Real-Time Oncology Review (RTOR) : Draft Guidance for Industry (published 22-Jul-2022)
Monthly FDA Approvals
Approval Date: 07/08/2022
Drug Name: BLUDIGONDA #216264
Active Ingredients: INDIGOTINDISULFONATE SODIUM
Submission Classification*: Type 7 - Drug Already Marketed without Approved NDA
Review Priority**: Standard
Company: PROVEPHARM SAS
Approval Date: 07/14/2022
Drug Name: BENDAMUSTINE HYDROCHLORIDENDA #216078
Active Ingredients: BENDAMUSTINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: CELERITY PHARMS
Approval Date: 07/15/2022
Drug Name: ZONISADENDA #214273
Active Ingredients: ZONISAMIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY
Approval Date: 07/15/2022
Drug Name: PACLITAXELNDA #216338
Active Ingredients: PACLITAXEL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: TEVA PHARMS
Approval Date: 07/18/2022
Drug Name: LUMRYZNDA #214755
Active Ingredients: SODIUM OXYBATE
Submission Classification*:
Review Priority**: Standard
Company: AVADEL CNS PHARMA LLC
Approval Date: 07/19/2022
Drug Name: PEMETREXEDNDA #214408
Active Ingredients: PEMETREXED
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ACCORD HLTHCARE INC
Approval Date: 07/20/2022
Drug Name: MIDAZOLAM IN 0.8% SODIUM CHLORIDENDA #215868
Active Ingredients: MIDAZOLAM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: EXELA PHARMA
Approval Date: 07/26/2022
Drug Name: BORTEZOMIBNDA #215441
Active Ingredients: BORTEZOMIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: INTAS PHARMS USA
Approval Date: 07/27/2022
Drug Name: PACLITAXELNDA #211875
Active Ingredients: PACLITAXEL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HBT LABS INC
Approval Date: 07/27/2022
Drug Name: KYZATREXNDA #213953
Active Ingredients: TESTOSTERONE UNDECANOATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MARIUS PHARMACEUTICALS, LLC
Approval Date: 07/27/2022
Drug Name: BORTEZOMIBNDA #215331
Active Ingredients: BORTEZOMIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MAIA PHARMS INC
Approval Date: 07/29/2022
Drug Name: ZORYVENDA #215985
Active Ingredients: ROFLUMILAST
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ARCUTIS BIOTHERAPEUTICS, INC.
Upcoming Advisory Committee Meetings
None for August
FDA publishes two critical DSCSA draft guidances (published 05-Jul-2022)
Health policy experts call for stronger accelerated approval reforms (published 06-Jul-2022)
European Commission adopts common specifications for high-risk IVDs (published 06-Jul-2022)
Drugmakers seek details on use of ctDNA as a biomarker or early endpoint (published 07-Jul-2022)
RAPS announces board slate for term beginning in 2023 (published 08-Jul-2022)
Personalized medicine growth hindered by outmoded drug development paradigm (published 11-Jul-2022)
Proposed legislation takes aim at prescription drug advertising (published 11-Jul-2022)
EMA: Pilot bringing ex-EU regulators to COVID product meetings was a success (published 12-Jul-2022)
Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized (published 12-Jul-2022)
EMA to explore reviewing raw data from clinical trials in applications (published 12-Jul-2022)
FDA finalizes instructions for use guidance for drugs, biologics (published 14-Jul-2022)
European Commission proposes overhaul of blood, tissues and cells regulation (published 18-Jul-2022)
Industry asks FDA to expand scope of product quality assessment guidance (published 18-Jul-2022)
Pharmaceutical industry groups suggest modifications to ICH Q9 guideline (published 19-Jul-2022)
FDA offers new guidance on therapeutic equivalence evaluations (published 20-Jul-2022)
Dose banding: FDA aims to reduce drug waste in new labeling guidance (published 20-Jul-2022)
FDA warning letter tells Spanish API firm to up its validation game (published 22-Jul-2022)
FDA describes plans to expand remote regulatory assessments (published 22-Jul-2022)
EMA consults on ICH M12 guideline for drug-drug interaction studies (published 25-Jul-2022)
FOCR offers path for validating ctDNA as an early endpoint for drug approval (published 25-Jul-2022)
FDA explains the ins and outs of real-time oncology review program in new guidance (published 26-Jul-2022)
Neonatal drug development addressed in FDA final guidance (published 27-Jul-2022)
FDA finalizes ANDA CRL, Orange Book Q&A guidances (published 27-Jul-2022)
EMA to address nitrosamine impurities in upcoming revision of active substances guidance (published 28-Jul-2022)
FDA finalizes guidance on including patients with incurable cancers in oncology trials (published 29-Jul-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