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Chief Medical Officer Summit -CMO 360°
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January 2020
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 in January 2020.
Finalized Draft Guidance Documents:
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Guidance for Industry (Published 28JAN2020)
Human Gene Therapy for Hemophilia Guidance for Industry (Published 28JAN2020)
Human Gene Therapy for Rare Diseases Guidance for Industry (Published 28JAN2020)
Human Gene Therapy for Retinal Disorders Guidance for Industry (Published 28JAN2020)
Long Term Follow-Up After Administration of Human Gene Therapy Products Guidance for Industry (Published 28JAN2020)
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Guidance for Industry (Published 28JAN2020)
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry (Published 24JAN2020)
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (Published 23JAN2020)
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (Published 23JAN2020)
In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (Published 23JAN2020)
New Draft Guidance Documents:
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations Draft Guidance for Industry (Published 27Jan2020)
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers Guidance for Industry Draft Guidance (15JAN2020)
EMA, MHRA Post Last-Minute Brexit Information (Published 31Jan2020)
Revised MAPP Tightens FDA Scope for Prioritized Generic Drug Applications (Published 31Jan2020)
Hahn Stresses Importance of Data, RWE in First All-Hands Meeting (Published 30Jan2020)
Microsoft launches 5-year, $40M AI initiative in global health (Published 30Jan2020)
FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data (Published 29Jan2020)
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products (Published 28Jan2020)
OPDP Plots Research on Indication, Endpoint Perceptions in Cancer Drug TV Ads (Published 28Jan2020)
FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures (Published 28Jan2020)
Asia Regulatory Roundup: China’s NMPA Steps up Oversight of Epidemic Prevention and Control Products (Published 28Jan2020)
FDA Finalizes 6 Gene Therapy Guidances, Unveils a New Draft (Published 28Jan2020)
FDA Finalizes 2018 Guidance on Use of Minimal Residual Disease (Published 24Jan2020)
FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer (Published 23Jan2020)
FDA Seeks Help Using Algorithms to Detect Adverse Event Anomalies (Published 23Jan2020)
FDA, MHRA Officials Stress the Criticality of Data Integrity in Clinical Trials (Published 23Jan2020)
The Essential List of Regulatory Authorities in Europe (Published 22Jan2020)
Drug Development Process for Biologics: Regulatory Expectations (Published 22Jan2020)
Transitional Leaders Take Charge as FDA Begins Phase III of OND Reorganization (Published 21Jan2020)
CDER to Launch Drug Risk Management Board (Published 21Jan2020)
RAPS' Regipedia, a Wiki Built for Regulatory Pros (Published 20Jan2020)
EMA, HMA Set 10 Priorities for Big Data (Published 20Jan2020)
FDA to Allow Online Submissions of Orphan Designation Requests (Published 17Jan2020)
MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports (Published 17Jan2020)
'CurAll' or 'Bestmab': FDA to Study How Proprietary Names Affect Perceptions (Published 17Jan2020)
How FDA Makes Decisions About REMS Requirements for Healthcare Providers (Published 16Jan2020)
Government Spending Bill Tweak Means 3 More NDAs Will Become BLAs, FDA Says (Published 15Jan2020)
FDA Offers Q&As on Submission of iPSPs for Cancer Drugs (Published 15Jan2020)
China’s Evolving Regulatory Environment: Special Report (Published 15Jan2020)
Nektar pulls NDA for pain drug after unanimous AdComm rejection (Published 15Jan2020)
Do FDA’s Reforms Need Reforming? Report Looks Back on 4 Decades (Published 14Jan2020)
EMA Recommends Fewer New and Orphan Drugs in 2019 (Published 09Jan2020)
FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors (Published 09Jan2020)
FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports (Published 08Jan2020)
Complex Cancer Trials: Group of UK Experts Offers Recommendations (Published 08Jan2020)
The Essential List of Regulatory Authorities in Asia (Published 07Jan2020)
WHO Drafts Policy on Designating Regulators as Listed Authorities (Published 07Jan2020)
FDA Updates Compliance Guide on Pre-approval Inspections for Drugs (Published 07Jan2020)
FDA: 2019 Continues Uptick in Orphan Drug Approvals (Published 06Jan2020)
Combination Products: New Guidance Details Process for Requesting Feedback From FDA (Published 06Jan2020)
Advertising, Promotion, Labeling and the Role of Social Media in Regulatory Communications (Published 02Jan2020)
- 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
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