Regulatory Guidance Monthly Review - July 2022

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.

 

Blog Image-Regulatory Guidanc eMonthly_FDAupdates-1

 

New FDA Guidance Documents

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format (published 15-Jul-2022)

Download FDA Guidance

Orange Book Questions and Answers Guidance for Industry:  Guidance for Industry (published 22-Jul-2022)

Download FDA Guidance

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry:  Guidance for Industry (published 22-Jul-2022)

Download FDA Guidance

 

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings:  Guidance for Industry (published 27-Jul-2022)

Download FDA Guidance

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry (published 27-Jul-2022)

Download FDA Guidance

 

 

FDA Draft Guidance

 

Identifying Trading Partners Under the Drug Supply Chain Security Act (published 05-Jul-2022)

Draft FDA Guidance

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry (published 06-Jul-2022)

Draft FDA Guidance

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)

Draft FDA Guidance

Real-Time Oncology Review (RTOR) : Draft Guidance for Industry (published 22-Jul-2022)

Draft FDA Guidance

 

 

 

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


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA publishes two critical DSCSA draft guidances (published 05-Jul-2022)

Read Article on RAPS.org

Health policy experts call for stronger accelerated approval reforms (published 06-Jul-2022)

Read Article on RAPS.org

European Commission adopts common specifications for high-risk IVDs (published 06-Jul-2022)

Read Article on RAPS.org

Drugmakers seek details on use of ctDNA as a biomarker or early endpoint (published 07-Jul-2022)

Read Article on RAPS.org

RAPS announces board slate for term beginning in 2023 (published 08-Jul-2022)

Read Article on RAPS.org

Personalized medicine growth hindered by outmoded drug development paradigm (published 11-Jul-2022)

Read Article on RAPS.org

Proposed legislation takes aim at prescription drug advertising (published 11-Jul-2022)

Read Article on RAPS.org

EMA: Pilot bringing ex-EU regulators to COVID product meetings was a success (published 12-Jul-2022)

Read Article on RAPS.org

Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized (published 12-Jul-2022)

Read Article on RAPS.org

EMA to explore reviewing raw data from clinical trials in applications (published 12-Jul-2022)

Read Article on RAPS.org

FDA finalizes instructions for use guidance for drugs, biologics (published 14-Jul-2022)

Read Article on RAPS.org

European Commission proposes overhaul of blood, tissues and cells regulation (published 18-Jul-2022)

Read Article on RAPS.org

Industry asks FDA to expand scope of product quality assessment guidance (published 18-Jul-2022)

Read Article on RAPS.org

Pharmaceutical industry groups suggest modifications to ICH Q9 guideline (published 19-Jul-2022)

Read Article on RAPS.org

FDA offers new guidance on therapeutic equivalence evaluations (published 20-Jul-2022)

Read Article on RAPS.org

Dose banding: FDA aims to reduce drug waste in new labeling guidance (published 20-Jul-2022)

Read Article on RAPS.org

FDA warning letter tells Spanish API firm to up its validation game (published 22-Jul-2022)

Read Article on RAPS.org

FDA describes plans to expand remote regulatory assessments (published 22-Jul-2022)

Read Article on RAPS.org

EMA consults on ICH M12 guideline for drug-drug interaction studies (published 25-Jul-2022)

Read Article on RAPS.org

FOCR offers path for validating ctDNA as an early endpoint for drug approval (published 25-Jul-2022)

Read Article on RAPS.org

FDA explains the ins and outs of real-time oncology review program in new guidance (published 26-Jul-2022)

Read Article on RAPS.org

Neonatal drug development addressed in FDA final guidance (published 27-Jul-2022)

Read Article on RAPS.org

FDA finalizes ANDA CRL, Orange Book Q&A guidances (published 27-Jul-2022)

Read Article on RAPS.org

EMA to address nitrosamine impurities in upcoming revision of active substances guidance (published 28-Jul-2022)

Read Article on RAPS.org

FDA finalizes guidance on including patients with incurable cancers in oncology trials (published 29-Jul-2022)

Read Article on RAPS.org

 


 

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