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Biotechgate Digital Partnering 2023
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September 2021
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 August 2021.
New FDA Guidance Documents:
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for Industry (published 29-Sep-2021)
Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry: Guidance for Industry (published 20-Sep-2021)
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry: Guidance for Industry (published 16-Sep-2021)
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry: COVID 19 Guidance (published 08-Sep-2021)
New Draft Guidance Documents:
Benefit-Risk Assessment for New Drug and Biological Products (published 29-Sep-2021)
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Draft Guidance for Industry (published 29-Sep-2021)
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment: Draft Guidance for Industry (published 28-Sep-2021)
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry (published 28-Sep-2021)
FDA revises MAPPs on data standards program, scientific interest groups (published 01-Sep-2021)
Read Article on RAPS.org
FDA proposes to refuse Intarcia’s exenatide combo product NDA —again (published 01-Sep-2021)
Read Article on RAPS.org
FDA convenes adcomm for Pfizer COVID booster (published 01-Sep-2021)
Read Article on RAPS.org
Top FDA and EMA officials to kick-off Convergence 2021 (published 02-Sep-2021)
Read Article on RAPS.org
JAK inhibitors' CV, cancer risks merit expanded boxed warning (published 02-Sep-2021)
Read Article on RAPS.org
Animal models have limitations for safety assessment of gene therapies: FDA adcomm (published 02-Sep-2021)
Read Article on RAPS.org
Analyses reveal wide variation in PRO measures in cancer trials (published 07-Sep-2021)
Read Article on RAPS.org
FDA extends comment period on ICH Q12 guidance (published 08-Sep-2021)
Read Article on RAPS.org
EU committee considers antimicrobial incentives, repurposing oncology drugs (published 08-Sep-2021)
Read Article on RAPS.org
FDA’s novel excipient pilot program opens for candidates (published 08-Sep-2021)
Read Article on RAPS.org
US to continue international inspection cooperation, says Marks (published 09-Sep-2021)
Read Article on RAPS.org
FDA updates guidance on generic drug development during COVID (published 09-Sep-2021)
Read Article on RAPS.org
Kaleido warned; FDA not persuaded by 'medical food' claim (published 09-Sep-2021)
Read Article on RAPS.org
HMA-EMA plans real-world metadata framework for regulatory decision-making (published 10-Sep-2021)
Read Article on RAPS.org
Industry calls for withdrawal of FDA electronic tracing guidance (published 10-Sep-2021)
Read Article on RAPS.org
Convergence: Regulatory considerations in advancing gene and cellular therapies (published 13-Sep-2021)
Read Article on RAPS.org
Convergence: EMA study reveals need for RWE framework, submission structure (published 14-Sep-2021)
Read Article on RAPS.org
Tips for avoiding regulatory pitfalls in pediatric drug development (published 14-Sep-2021)
Read Article on RAPS.org
Global regulatory workforce nearly 100K, says new report from RAPS, Elemed (published 15-Sep-2021)
Read Article on RAPS.org
Convergence: Inadequate testing of cell and gene therapies draws FDA concern (published 15-Sep-2021)
Read Article on RAPS.org
FDA, EMA launch complex generic, hybrid product advice pilot (published 15-Sep-2021)
Read Article on RAPS.org
FDA continues data modernization with new Office of Digital Transformation (published 16-Sep-2021)
Read Article on RAPS.org
FDA guidance covers frequently asked CMC questions for generic drugs (published 21-Sep-2021)
Read Article on RAPS.org
Review highlights lack of consistency in FDA’s ‘close call’ approvals (published 23-Sep-2021)
Read Article on RAPS.org
WHO seeks input on medicines to prioritize for BCS-based biowaivers (published 27-Sep-2021)
Read Article on RAPS.org
Drugs for non-TB pulmonary disease see new FDA guidance (published 28-Sep-2021)
Read Article on RAPS.org
FDA issues draft guidance on electronic 510(k) submissions (published 28-Sep-2021)
Read Article on RAPS.org
FDA issues draft guidance on RWD sourced from EHRs, claims data (published 29-Sep-2021)
Read Article on RAPS.org
For gene therapies, FDA drafts trial guidance, finalizes "sameness" for orphan exclusivity (published 30-Sep-2021)
Read Article on RAPS.org
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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