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August 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:
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)
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New Draft Guidance Documents: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Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer: Draft Guidance for Industry (published 25Aug2021)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
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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