Approval history
Every NDA, ANDA and BLA by brand, ingredient or sponsor, with the first approval, the latest action, the submission count and the label PDF.
Live now
Live from the FDA record
The FDA moves every day. See it first.
ReqRX turns the FDA's public record into signals you can act on: approvals, label changes, drug shortages, recalls and device clearances. It's built for the companies that make, buy and invest in drugs and devices, with 30 years of FDA and patent counsel at the table.
Public FDA data, queried live
No patient data, ever
Drugs, biologics and devices
reqrx / signal searchLIVE
Source: openFDA (api.fda.gov), queried as you typeFull console + CSV export →
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Drug packages listed in current shortage
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Drug recall reports in
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510(k) device decisions in
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Device recall reports in
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Signal tape
The platform
One record. Every move FDA makes, in one place.
The FDA publishes its decisions across many databases in many formats. ReqRX reads all of them, links them by product, and tells you what changed and why it matters to your business.
Shortage radar
FDA's drug shortage list, grouped by product and maker. A shortage is a supply problem for hospitals and a market opening for manufacturers and 503B facilities.
Live nowRecall watch
Drug enforcement reports by product, firm and class, newest first, so distributors and buyers see their exposure before the phone rings.
Live nowPredicate finder
More than 176,000 510(k) decisions, searchable by device name, applicant, K-number or product code. Find your predicate before you pay for testing.
Live nowPathway navigator
Answer a few questions to get the likely FDA route (505(b)(1), 505(b)(2), ANDA, BLA, 351(k), 510(k), De Novo or PMA), its review clock and its protection.
Live nowExclusivity clock
NCE, orphan, pediatric, GAIN and biologic exclusivity dates calculated from an approval date, with the year-4 filing windows called out.
Live nowWatchlists and alerts
Follow a molecule, a competitor or a product code. Get one morning brief when anything on your list moves: a new approval, a label change, a shortage or a recall.
In buildLoss-of-exclusivity calendar
Orange Book patents and exclusivities and Purple Book biologics on one timeline, so you can see which brands open to generics and biosimilars, and when.
In buildLabel-change diff
When a label is revised, see exactly what changed: new warnings, new indications, dosing. Section by section, side by side.
In buildWho it's for
For the people who bring medicine to market, not the people who dispense it.
ReqRX is not a pharmacy and never touches a prescription. It is intelligence for the business side of drugs and devices.
01
Generic and 505(b)(2) developers
Pick targets the record already points to.
- Shortages with few active makers
- Brands nearing loss of exclusivity
- Reference-drug label history
02
503B outsourcing facilities
The FDA shortage list shapes what a 503B facility can make. Watch it daily instead of weekly.
- New and revised shortage postings
- Resolved entries, the day they flip
- Export to your planning sheet
03
Hospital and health-system supply
See shortages and recalls by product before they reach the floor.
- Recall class and status at a glance
- Shortage availability and next delivery
- Watchlists by formulary
04
Medtech founders
Know your pathway and predicate before you spend on testing.
- Predicate search by product code
- Competitor clearances as they post
- 510(k) vs De Novo vs PMA
05
Foreign companies entering the U.S.
The FDA map, in plain English, for teams coming from the EU, Asia and Israel.
- Which pathway, which center, which clock
- Who has already cleared similar devices
- IP strategy before first disclosure
06
Investors and BD teams
Diligence on a target's regulatory story in minutes, not weeks.
- Full approval and supplement history
- Recall and shortage track record
- Exclusivity runway
Try it
Two questions every team asks. Answered here.
Which FDA pathway are we on, and how long is the runway? Both tools below run in your browser. Nothing you enter leaves the page.
Pathway navigator
Get the likely route to market, its review clock and its protection.
Exclusivity clock
Enter an approval date and an exclusivity type to see the date it ends.
Exclusivity ends
Statutory exclusivity only. Patents, 30-month stays, forfeiture and litigation can move the real date. Check the Orange Book or Purple Book and your counsel.
Counsel at the table
Software reads the record. Counsel reads between the lines.
Data shows you what happened. Deciding what to do next takes judgment. When a signal turns into a decision about a filing, a patent or a market entry, ReqRX connects you to regulatory and IP counsel who have walked drugs and devices through the FDA for three decades.
- Pathway and submission strategy505(b)(2) vs ANDA, 510(k) vs De Novo, and how to frame the predicate or the reference drug.
- Patent and exclusivity strategyOrange Book listings, Paragraph IV exposure, and protecting what exclusivity does not cover.
- Diligence for dealsA target's regulatory record and IP position, reviewed before you sign.
- U.S. market entryFor foreign drug and device companies: the FDA route and the U.S. patent plan, together.
Access
Start free. Scale to your whole portfolio.
Founding members set the roadmap and get founding terms when paid plans open.
Watch
Free
For anyone checking the record.
- Live search: approvals, shortages, recalls, 510(k)
- Pathway navigator and exclusivity clock
- CSV export of any result
Pro
Signal
For regulatory, supply and BD teams.
Founding terms at launch
- Watchlists on molecules, firms and product codes
- Daily morning brief by email
- Label-change diff
- Loss-of-exclusivity calendar
Enterprise
Portfolio
For manufacturers, health systems and funds.
Scoped to your portfolio
- Portfolio-wide monitoring and API
- Custom shortage and LOE target lists
- Counsel review on request
Founding access
Get the signal before the market does.
Tell us what you watch. We open Signal to founding members first and build the watchlists around real portfolios.
- No spam, no resaleWe use your details only to contact you about ReqRX.
- Business data onlyReqRX never collects patient or prescription information.