Regulatory Guidance Monthly Review - November 2020

November 2020 


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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 November 2020.

 

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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New Draft Guidance Documents: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Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry DRAFT GUIDANCE (Published 30Nov2020)

Download DRAFT Guidance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)

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Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act Guidance for Industry DRAFT GUIDANCE (Published 19Nov2020)

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Cross Labeling Oncology Drugs in Combination Regimens Guidance for Industry DRAFT GUIDANCE (Published 19Nov2020)

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Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

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

 


 

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