Regulatory Guidance Monthly Review - Aug 2021

August 2021 


Veristat_SM_Reg Guidance Aug 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.

 

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New FDA Guidance Documents:

 

Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH):  Guidance for Industry Technical Specifications Document (published 31Aug2021)

Download FDA Guidance

 

FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency:  Guidance for Industry, Investigators, and Institutional Review Boards (published 30Aug2021)

Download FDA Guidance

 

Development and Submission of Near Infrared Analytical Procedures (published 06Aug2021)

Download FDA Guidance

 

Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials (published 06Aug2021)

Download FDA Guidance

 

New Draft Guidance Documents:

 

Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer: Draft Guidance for Industry (published 25Aug2021)

Download Draft FDA Guidance

 

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (published 20Aug2021)

Download Draft FDA Guidance


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

CBO: Proposed Medicare pricing plan could curb drug development (published 30-Aug-2021)

Read Article on RAPS.org

 

The changing regulatory landscape for laboratory developed tests (published 30-Aug-2021)
Read Article on RAPS.org

 

EMA goes all in on big data (published 27-Aug-2021)
https://www.raps.org/news-and-articles/news-articles/2021/8/ema-goes-all-in-on-big-data?feed=Regulatory-Focus

 

Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials (published 27-Aug-2021)
Read Article on RAPS.org

 

FDA warns Japanese firm for particle contamination, takes mask-maker to task — again (published 26-Aug-2021)
Read Article on RAPS.org

 

Industry lauds PDUFA VII focus on innovation, transparency (published 26-Aug-2021)
Read Article on RAPS.org

 

Cancer immunotherapy alternative dosing regimens: New FDA draft guidance (published 25-Aug-2021)
Read Article on RAPS.org

 

FDA: No plans yet to resume onsite GMP foreign inspections (published 25-Aug-2021)
Read Article on RAPS.org

 

FDA issues 39 new and revised product-specific guidances (published 25-Aug-2021)
Read Article on RAPS.org

 

FDA fleshes out models for safe continuous manufacture of therapeutic proteins (published 24-Aug-2021)
Read Article on RAPS.org

 

PDUFA VII commitment letter: RWE, rare diseases see renewed attention (published 23-Aug-2021)
Read Article on RAPS.org

 

FDA approves Comirnaty as first COVID vaccine (published 23-Aug-2021)
Read Article on RAPS.org

 

FDA studies consumer perception of DTC drug ads, willingness to report false claims (published 20-Aug-2021)
Read Article on RAPS.org

 

FDA report: Drug quality tops OPQ's list of product defects (published 19-Aug-2021)
Read Article on RAPS.org

 

Working group: More guidance needed on MRD in myeloma trials (published 19-Aug-2021)
Read Article on RAPS.org

 

FDA, with academic and community partners, launches first pediatric ECG warehouse (published 18-Aug-2021)
Read Article on RAPS.org

 

FDA-registered sites declined in 2020: OPQ drug quality report (published 17-Aug-2021)
Read Article on RAPS.org

 

Eton’s Alkindi ads draw third OPDP untitled letter of 2021 (published 16-Aug-2021)
Read Article on RAPS.org

 

ICMRA: Address artificial intelligence challenges with permanent working group (published 16-Aug-2021)
Read Article on RAPS.org

 

FDA FY2022 user fee table (published 13-Aug-2021)
Read Article on RAPS.org

 

FDA seeks input on pre-Hatch-Waxman ‘PANDA’ applications (published 12-Aug-2021)
Read Article on RAPS.org

 

Lilly 483 report offers insights from site making COVID antibodies (published 12-Aug-2021)

Read Article on RAPS.org

 

FDA official: Agency will not extend 2023 DSCSA interoperability deadline (published 11-Aug-2021)
Read Article on RAPS.org

 

Analysis: Real-world studies of cancer drugs suffer from poor quality (published 11-Aug-2021)
Read Article on RAPS.org

 

Industry seeks changes to FDA’s enteral tube-administered drugs guidance (published 10-Aug-2021)
Read Article on RAPS.org

 

Two more stem cell firms slapped with untitled letters (published 10-Aug-2021)
Read Article on RAPS.org

 

After court defeat, FDA shifts to regulating some drugs as devices (published 09-Aug-2021)
Read Article on RAPS.org

 

FDA finalizes guidance on metastasis-free survival as an endpoint for prostate cancer trials (published 06-Aug-2021)
Read Article on RAPS.org

 

Near-infrared guidance finalized for small molecule testing, with biologics to come (published 06-Aug-2021)
Read Article on RAPS.org

 

WHO revises guidance on GMPs for investigational products, R&D facilities (published 05-Aug-2021)
Read Article on RAPS.org

 

FDA’s ASCA pilot grows; first lab accredited for biocompatibility testing (published 05-Aug-2021)
Read Article on RAPS.org

 

FDA's FY2022 Senate funding bill clears Appropriations committee (published 05-Aug-2021)
Read Article on RAPS.org

 

Notified bodies report success — and some drawbacks — using remote audits (published 04-Aug-2021)
Read Article on RAPS.org

 

HHS OIG to review FDA’s use of accelerated approval pathway (published 04-Aug-2021)
Read Article on RAPS.org

 

EFPIA, others question EC's proposed orphan and pediatric drug development updates (published 04-Aug-2021)
Read Article on RAPS.org

 

FDA finalizes long-awaited intended use rule (published 02-Aug-2021)

Read Article on RAPS.org

 

CTIS set to launch in EU; sponsor guide now online (published 02-Aug-2021)

Read Article on RAPS.org

 


 

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