FDA event monitoring · v1 launching
Real-time alerts on FDA's Complete Response Letters and warning letters, routed to the biotech RA team that needs them. Coverage expanding to AdComm, guidance documents, and clinical holds in v1.1. Built for biotech RA, not for traders.
Founder offer · first 50 customers grandfathered at $249/mo for 24 months.
01 / Why RegPharma
FDA started publishing Complete Response Letters in September 2025 under its radical-transparency policy. We index every one, link to FDA's source, and alert you when a sponsor on your watchlist receives one. Cortellis, Citeline, and Redica all consume the same feed — we're the only ones publishing it.
Rhizome AI answers “what does FDA think about X?” We answer “what just happened to a biotech I'm tracking?” Different work; we're complementary, not competing. Use both if it helps.
Every alert footer states our source explicitly with a direct link to FDA. CRL lag is ~3 weeks behind FDA publication; warning letters ~8 days — we don't pretend to be faster than the source. When clinical-hold alerts ship in v1.1, every alert will disclose the ~70–80% coverage limit explicitly. No “we cover everything.”
02 / Coverage
Two live feeds at launch; three more rolling out in the weeks after. Source, freshness, and coverage are disclosed on every row — and on every alert.
| Source | Data | Freshness | Coverage |
|---|---|---|---|
|
Complete Response Letters
openFDA
|
439+ CRLs (Sept 2025 forward), full OCR text, sponsor + drug + cited deficiencies | ~3 wk lag (FDA batched) |
All public NDAs/BLAs |
|
Warning Letters
FDA datatables
|
3,474+ letters, company + issuing office + subject + response/closeout | ~8 day lag | All public warning letters |
| Source | Data | Freshness | Coverage |
|---|---|---|---|
|
Advisory Committee
BiopharmaCatalyst
|
Meeting schedule + agenda + products under review | ~30+ days advance + same-day decisions |
All public AdComm meetings |
|
Guidance Documents
FDA datatables
|
All new/revised guidance, by therapeutic area + center (CDER/CBER/CDRH) | Real-time | Comprehensive |
|
Clinical Holds
SEC EDGAR press-wire
|
Disclosed clinical holds for biotechs on your watchlist | Real-time (with caveats) |
~70–80%: public companies via SEC EDGAR + voluntarily-disclosed private via press-wire. Not 100% — we tell you on every alert. |
Not in v1 or v1.1: 483 inspection observations. These require FOIA workflows that we'd compete with Redica on — and Redica has a 5-year head start. We may surface adjacent inspection signals later; we'll be transparent about coverage when we do.
03 / Positioning
We don't compete with the enterprise databases or with research assistants. We sit in a different lane: cheap, fast event monitoring on the watchlist your RA team already maintains.
| Cortellis / Citeline / Redica | Rhizome AI | RegPharma | |
|---|---|---|---|
| Pricing | $20K–$200K+/yr | $400/mo + custom | $249–$499/mo |
| Job to be done | Comprehensive database + workflow | Q&A research | Event monitoring with watchlist matching |
| Setup | 30–90 day procurement + onboarding | Sign-up | Same-day |
| CRLs | Index from FDA feed (no published archive) | Not in 2.5TB corpus (predates Sept 2025) | Public archive + watchlist alerts |
| Editorial | Expert summaries | None (citations only) | Coming in v1.5 |
| Buyer | Enterprise RA at top 20 pharma | RA / R&D / Quality teams broadly | Series B/C biotech with pivotal-stage assets |
04 / Pricing
Self-serve, no procurement friction, fits the "tools & subscriptions" line at most Series B/C biotechs.
$249/mo
Founder offer
$249/mo · 24 mo
$499/mo
What's not included: editorial commentary on individual CRLs (coming in v1.5; tracked, not opinionated), 483 inspection observations (coming if/when broader inspection-data access becomes available), regulatory advice (we don't give it — see Trust & transparency).
05 / Trust
Four standing commitments about how we source, label, and scope what we sell.
06 / FAQ
A CRL is FDA's formal response when it cannot approve an NDA or BLA in its current form, citing specific deficiencies. Before September 2025, CRLs were not public — sponsors received them privately. Under FDA's radical-transparency policy, all CRLs are now published via openFDA.
Clinical holds are not proactively published by FDA. We surface them via (a) SEC EDGAR 8-K filings for public companies (real-time) and (b) press-wire monitoring for private companies that voluntarily disclose. Coverage: ~70–80%. Every clinical-hold alert footer states this explicitly. We never claim “all” clinical holds.
Rhizome answers regulatory questions with citations from a 2.5TB corpus. We monitor FDA's event feeds and route them to your watchlist. Different jobs — many RA teams will want both. We're not a substitute.
They sell comprehensive enterprise platforms with workflow + expert summaries at $20K–$200K+/yr. We sell event monitoring for the watchlist you specify at $249–$499/mo. Smaller scope; smaller price; faster to start.
No. We are an informational service. Our alerts surface FDA-published data. They do not constitute regulatory, legal, or investment advice.
Our service is not designed or licensed for use in investment decisions. PDUFA / AdComm / CRL alerts can move biotech stocks; we are not a financial-data service and you should not rely on us for trading decisions.
Self-serve, no procurement friction, fits the “tools & subscriptions” budget at most Series B/C biotechs. We grandfather the first 50 customers at this price for 24 months even when we change public pricing.