2 min read
ASCO Annual Meeting
Meet Veristat at the 2025 ASCO Annual Meeting
Advancing Oncology Therapies for Patients in Need
Veristat is proud to...
4 min read
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.
New FDA Guidance Documents
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry: Guidance for Industry (published 24-Jun-2022)
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry (published 27-Jun-2022)
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FDA Draft Guidance
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Draft Guidance for Industry (published 15-Jun-2022)
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for Industry (published 24-Jun-2022)
Considerations for Rescinding Breakthrough Therapy Designation (published 24-Jun-2022)
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Draft Guidance for Industry (published 27-Jun-2022)
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (published 29-Jun-2022)
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
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)
Former FDA officials call for more transparency for drug approvals (published 15-Jun-2022)
Clinical trial diversity: Sponsors seek clarity on data sources, timing (published 15-Jun-2022)
House subcommittee moves FDA $3.6B budget forward (published 15-Jun-2022)
VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children (published 15-Jun-2022)
CBER outlines recognition process for regenerative medicine therapy standards (published 17-Jun-2022)
FDA caught up on domestic preapproval inspections, foreign inspections still a challenge (published 20-Jun-2022)
DIA: Global initiative to standardize CMC quality data gaining steam (published 22-Jun-2022)
Draft guidance outlines FDA’s testing requirements for tissue containment systems (published 22-Jun-2022)
FDA prevented record number of drug shortages in 2021 (published 22-Jun-2022)
RWD in clinical trials: External control arms take the lead (published 23-Jun-2022)
FDA explains when it will rescind breakthrough designations (published 23-Jun-2022)
House committee sends FDA budget to floor vote (published 23-Jun-2022)
DIA: Experts offer advice on conducting decentralized trials (published 24-Jun-2022)
FDA to form task force, public-private partnership on rare neurodegenerative diseases (published 24-Jun-2022)
Oligonucleotides: FDA drafts clinical pharmacology guidance (published 27-Jun-2022)
FDA official: Virtual audits, records requests may be sticking around (published 27-Jun-2022)
VRBPAC recommends addition of Omicron-component to future boosters (published 28-Jun-2022)
Former FDA cybersecurity guru warns of ‘catastrophe’ without dedicated staff (published 29-Jun-2022)
CAR T cell product development guidance: Comments ask for CMC details (published 29-Jun-2022)
ICMRA explores hybrid inspections, postapproval changes with new pilots (published 29-Jun-2022)
FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use (published 30-Jun-2022)
PFDD: Draft guidance seeks to demystify clinical outcomes assessments (published 30-Jun-2022)
-
Review the recording from our webinar: How to Better Plan Your Virtual Clinical Trial
-
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