Following the regulatory record on how medicines are made, tested and approved.
We review FDA records, inspection findings and public filings on how medicines are manufactured and authorized, and publish what we find with the source documents attached, so readers can weigh the evidence for themselves.
Areas of inquiry
Manufacturing compliance
What current Good Manufacturing Practice regulations require, and what inspection records and filings show about adherence.
Read the cGMP reviewThe advisory committee record
Public comment and the committee vote from FDA's June 28, 2022 Vaccines and Related Biological Products Advisory Committee meeting.
Watch the testimony and the voteResearch and source documents
Papers, regulations and records referenced in our work, each described and linked to its original source.
Open the document libraryFrom the document library
All documents| Document | Topic | Format |
|---|---|---|
| VRBPAC public comment video, June 2022 (starts at 5:18:05) | Advisory committee testimony | Video |
| VRBPAC committee vote, June 2022 (starts at 8:16:32) | Advisory committee vote | Video |
| VRBPAC public comment slides, June 2022 | Advisory committee testimony | PPTX |
| Exhibit 1: Evidence of cGMP/cGxP non-compliance | Manufacturing compliance | Web page |
| cGMP evidence summary (Latypova, TrialSite News, 2022) | Manufacturing compliance | Web page |
| Perez, Moret-Chalmin and Montagnier, CJD case series (May 2022 preprint) | Research | |
| Herrmann et al., prion neurotoxicity, PLoS Pathogens (2015) | Research |
Our standards
Primary sources first
Every claim links to the document it comes from.
Responses alongside findings
Where agencies or manufacturers have responded, their position appears next to ours.
Corrections in the open
Errors are corrected, dated and logged publicly.
Nonpartisan
We do not endorse candidates or parties.
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