Regulatory Guidance Monthly Review - June 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 June 2022.

 

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New FDA Guidance Documents

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry:  Guidance for Industry (published 24-Jun-2022)

Download FDA Guidance

 

Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment:  Guidance for Industry (published 27-Jun-2022)

Download FDA Guidance

 

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment:  Guidance for Industry (published 28-Jun-2022)

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment - Guidance for Industry (fda.gov)

 

 

FDA Draft Guidance

 

Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Draft Guidance for Industry (published 15-Jun-2022)

Draft FDA Guidance

 

Non-Penicillin Beta-Lactam Drugs:  A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for Industry (published 24-Jun-2022)

Draft FDA Guidance

 

Considerations for Rescinding Breakthrough Therapy Designation (published 24-Jun-2022)

Draft FDA Guidance

 

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Draft Guidance for Industry (published 27-Jun-2022)

Draft FDA Guidance

 

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (published 29-Jun-2022)

Draft FDA Guidance

 

 

Monthly FDA Approvals

 

Approval Date: 06/02/2022
Drug Name: TESTOSTERONE CYPIONATENDA #216318
Active Ingredients: TESTOSTERONE CYPIONATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SLAYBACK PHARMA LLC

Approval Date: 06/03/2022
Drug Name: ACETAMINOPHENNDA #206968
Active Ingredients: ACETAMINOPHEN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: INNOPHARMA

Approval Date: 06/10/2022
Drug Name: PEMETREXEDNDA #208746
Active Ingredients: PEMETREXED DITROMETHAMINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: HOSPIRA

Approval Date: 06/13/2022
Drug Name: AMVUTTRANDA #215515
Active Ingredients: VUTRISIRAN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ALNYLAM PHARMS INC

Approval Date: 06/16/2022
Drug Name: SKYRIZIBLA #761262
Active Ingredients: RISANKIZUMAB-RZAA
Submission Classification*:
Review Priority**:
Company: ABBVIE INC

Approval Date: 06/17/2022
Drug Name: PHEBURANENDA #216513
Active Ingredients: SODIUM PHENYLBUTYRATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MEDUNIK

Approval Date: 06/22/2022
Drug Name: PEMETREXEDNDA #214218
Active Ingredients: PEMETREXED
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HOSPIRA INC

Approval Date: 06/23/2022
Drug Name: RELEXXIINDA #216117
Active Ingredients: METHYLPHENIDATE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: OSMOTICA PHARM CORP

Approval Date: 06/29/2022
Drug Name: VENBYSI XRNDA #215429
Active Ingredients: VENLAFAXINE BESYLATE
Submission Classification*: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Review Priority**: Standard
Company: ALMATICA

 

Upcoming Advisory Committee Meetings


None for July


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA withdraws cancer drug approval after finding possible higher death rates (published 01-Jun-2022)Read Article on RAPS.org

 

Experts say FDA enforcement focus unchanged, use of alternative tools to grow (published 01-Jun-2022)Read Article on RAPS.org

 

ICH details milestones reached on guidelines after Athens meeting (published 02-Jun-2022)Read Article on RAPS.org

 

EU regulators offer new guidance on complex clinical trials (published 03-Jun-2022)Read Article on RAPS.org

 

Cavazzoni: Pandemic-era tools, learnings are here to stay (published 07-Jun-2022)Read Article on RAPS.org

 

FDA’s OPDP takes Althera to task over cholesterol drug promotion (published 07-Jun-2022)Read Article on RAPS.org

 

Expert proposes changes to accelerated approval reforms in user fee bills (published 08-Jun-2022)Read Article on RAPS.org

 

Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests (published 09-Jun-2022)Read Article on RAPS.org

 

All eyes on Senate after House passes user fee reauthorization bill (published 09-Jun-2022)Read Article on RAPS.org

 

Study: FDA approves new oncology drugs quicker than EMA (published 10-Jun-2022)Read Article on RAPS.org

 

VRBPAC unanimously backs Moderna vaccine for children 6 and up (published 14-Jun-2022)

Read Article on RAPS.org

 

Former FDA officials call for more transparency for drug approvals (published 15-Jun-2022)

Read Article on RAPS.org

 

Clinical trial diversity: Sponsors seek clarity on data sources, timing (published 15-Jun-2022)

Read Article on RAPS.org

 

House subcommittee moves FDA $3.6B budget forward (published 15-Jun-2022)

Read Article on RAPS.org

 

VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children (published 15-Jun-2022)

Read Article on RAPS.org

 

CBER outlines recognition process for regenerative medicine therapy standards (published 17-Jun-2022)

Read Article on RAPS.org

 

FDA caught up on domestic preapproval inspections, foreign inspections still a challenge (published 20-Jun-2022)

Read Article on RAPS.org

 

DIA: Global initiative to standardize CMC quality data gaining steam (published 22-Jun-2022)

Read Article on RAPS.org

 

Draft guidance outlines FDA’s testing requirements for tissue containment systems (published 22-Jun-2022)

Read Article on RAPS.org

 

FDA prevented record number of drug shortages in 2021 (published 22-Jun-2022)

Read Article on RAPS.org

 

RWD in clinical trials: External control arms take the lead (published 23-Jun-2022)

Read Article on RAPS.org

 

FDA explains when it will rescind breakthrough designations (published 23-Jun-2022)

Read Article on RAPS.org

 

House committee sends FDA budget to floor vote (published 23-Jun-2022)

Read Article on RAPS.org

 

DIA: Experts offer advice on conducting decentralized trials (published 24-Jun-2022)

Read Article on RAPS.org

 

FDA to form task force, public-private partnership on rare neurodegenerative diseases (published 24-Jun-2022)

Read Article on RAPS.org

 

Oligonucleotides: FDA drafts clinical pharmacology guidance (published 27-Jun-2022)

Read Article on RAPS.org

 

FDA official: Virtual audits, records requests may be sticking around (published 27-Jun-2022)

Read Article on RAPS.org

VRBPAC recommends addition of Omicron-component to future boosters (published 28-Jun-2022)

Read Article on RAPS.org

Former FDA cybersecurity guru warns of ‘catastrophe’ without dedicated staff (published 29-Jun-2022)

Read Article on RAPS.org

CAR T cell product development guidance: Comments ask for CMC details (published 29-Jun-2022)

Read Article on RAPS.org

ICMRA explores hybrid inspections, postapproval changes with new pilots (published 29-Jun-2022)

Read Article on RAPS.org

FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use (published 30-Jun-2022)

Read Article on RAPS.org

PFDD: Draft guidance seeks to demystify clinical outcomes assessments (published 30-Jun-2022)

Read Article on RAPS.org


 

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