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November 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 for both COVID-19 related and non-COVID-19 related programs in November 2020.
New FDA Guidance Documents:
Compliance Policy Guide CPG Sec. 110.650 Weekly Entry Filing Guidance for Industry and FDA Staff (Published 30Nov2020)
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Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry (Published 24Nov2020)
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Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff (Published 24Nov2020)
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Investigational COVID-19 Convalescent Plasma Guidance for Industry (Published 16Nov2020)
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CERTIFICATES OF CONFIDENTIALITY Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff (Published 13Nov2020)
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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (Published 09Nov2020)
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Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry (Published 09Nov2020)
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Insanitary Conditions at Compounding Facilities Guidance for Industry (Published 06Nov2020)
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Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices (Published 06Nov2020)
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New Draft Guidance Documents:
Evaluation of Gastric pHDependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry DRAFT GUIDANCE (Published 30Nov2020)
Download DRAFT Guidance
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry DRAFT GUIDANCE (Published 23Nov2020)
Download DRAFT Guidance
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry DRAFT GUIDANCE (Published 19Nov2020)
Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry DRAFT GUIDANCE (Published 19Nov2020)
Download DRAFT Guidance
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate (Published 30Nov2020)
Read FDA News Release
Moderna files COVID vaccine EUA; adcomm set for 17 December (Published 30Nov2020)
Read Article on RAPS.org
FDA pilots program to encourage new drug development tools (Published 30Nov2020)
Read Article on RAPS.org
COVID-19 vaccine tracker (Published 30Nov2020)
Read Article on RAPS.org
Comparison of pharmaceutical development drug regulatory pathways in the US and China (Published 30Nov2020)
Read Article on RAPS.org
EC’s new pharmaceutical strategy highlights support for innovation, R&D (Published 25Nov2020)
Read Article on RAPS.org
CDC advisory committee ponders COVID vaccine priorities (Published 24Nov2020)
Read Article on RAPS.org
HHS moves to end FDA’s unapproved drugs initiative (Published 24Nov2020)
Read Article on RAPS.org
WHO proposes update of GMPs for investigational products (Published 24Nov2020)
Read Article on RAPS.org
FDA launches online orphan submissions portal (Published 24Nov2020)
Read Article on RAPS.org
COVID-19 therapeutics tracker (Published 23Nov2020)
Read Article on RAPS.org
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 (Published 21Nov2020)
Read FDA News Release
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate (Published 20Nov2020)
Read FDA News Release
PFIZER AND BIONTECH TO SUBMIT EMERGENCY USE AUTHORIZATION REQUEST TODAY TO THE U.S. FDA FOR COVID-19 VACCINE (Published 20Nov2020)
Read Pfizer Press Release
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 (Published 19Nov2020)
Read FDA News Release
FDA, Industry set priorities for BsUFA III (Published 19Nov2020)
Read Article on RAPS.org
Experts propose changes to FDA’s Accelerated Approval Program (Published 19Nov2020)
Read Article on RAPS.org
EMA sets 50% efficacy goal – with flexibility – for COVID vaccines (Published 19Nov2020)
Read Article on RAPS.org
EMA revises remote pharmacovigilance inspections guide (Published 18Nov2020)
Read Article on RAPS.org
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home (Published 17Nov2020)
Read FDA News Release
FDA commits to data transparency in COVID EUAs (Published 17Nov2020)
Read Article on RAPS.org
Hahn addresses EUAs, transition to approvals in conversation with RAPS members (Published 17Nov2020)
Read Article on RAPS.org
COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs (Published 17Nov2020)
Read FDA News Release
NIH director: Efficacy for co-developed Moderna vaccine nears 95% (Published 16Nov2020)
Read Article on RAPS.org
EMA rolls out COVID vaccine monitoring plan (Published 13Nov2020)
Read Article on RAPS.org
FDA warning letters in 2020 reveal concerns around purity, investigations, and data integrity (Published 13Nov2020)
Read Article on RAPS.org
Novel vaccines typically take 8 years of clinical development: Study (Published 10Nov2020)
Read Article on RAPS.org
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 (Published 09Nov2020)
Read FDA News Release
FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development (Published 09Nov2020)
Read FDA News Release
FDA seeks comment on plan to increase REMS transparency (Published 05Nov2020)
Read Article on RAPS.org
Marks fields questions on cell and gene therapy development (Published 05Nov2020)
Read Article on RAPS.org
- Learn about our Cell and Gene Therapy Center of Excellence
- Discover our expanded Pharmacovigilance service offering through the acquisition of Certus PV.
- Explore the Veristat COVID-19 Resource page
- Download our COVID-19 Guide on Strategie 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