GxP intelligence, decoded for practitioners.

Federal Register · refreshed dailyOpen →

Regulatory Changes

Every FDA rule, proposed rule and notice from the Federal Register, with the rules separated from the administrative volume.

Federal Register · FDA · refreshed dailyOpen →

Regulatory Feed

Federal Register documents, FDA recalls and curated milestones in one running register, cut by source, type and period.

fda.gov · refreshed dailyOpen →

FDA Guidance Tracker

Newly issued FDA guidance, draft and final, with its status — including the drafts the Federal Register feed misses.

ema.europa.eu · refreshed dailyOpen →

EMA Updates

EMA scientific guidelines, concept papers, consultations, committee documents and withdrawn applications.

What Changed

Regulatory changes mapped to the standards, disciplines and sectors each touches, and the artefact that closes it.

Weekly Briefing

Every issue of the Weekly GxP Briefing — what changed across FDA, EMA, MHRA and Health Canada, and the open deadlines.

SPEQ · MondaysOpen →

WHAT REGULATORS ARE ENFORCING

openFDA · refreshed dailyOpen →

FDA Enforcement

FDA drug, device and food recalls, searchable, with Class I/II/III trends mapped to GxP quality domains.

fda.gov · refreshed dailyOpen →

FDA Warning Letters

FDA warning letters back to 2021 by recipient and date; recent letters add the issuing office, subject and FDA’s text.

gov.uk · refreshed dailyOpen →

MHRA Alerts (UK)

MHRA Class 1–4 medicines recalls, field safety notices and device safety information, each linked.

canada.ca · refreshed every six hoursOpen →

Health Canada Recalls

Health Canada recalls and safety alerts for drugs, devices, natural health products and cosmetics.

EudraGMDP · refreshed dailyOpen →

EU GMP Non-Compliance

Sites EudraGMDP records as significantly non-compliant after inspection — the EU counterpart to a warning letter.

Import Refusals

A public snapshot of FDA import refusals; SPEQ Intelligence adds the country, industry, charge-code and trend analysis.

Public preview · Intelligence detail

WHAT HAPPENED AT A SITE OR FIRM

Company Dossier

A public signal preview for a firm; SPEQ Intelligence opens its named sites, recalls, warning letters and inspections.

FDA · openFDAOpen →

Public counts · Professional records

Inspection Classifications

Every FDA NAI/VAI/OAI classification since FY2009 as filterable counts; the named register opens with Professional.

fda.gov · refreshed weeklyOpen →

483s & Inspection Documents

Every Form 483, EIR and inspection record FDA has released, searchable by establishment, FEI, state and record type.

Public · Professional search

483 Observation Explorer

The most-cited FDA 483 observations, decoded by type; Professional adds full-text search across every observation.

483s by Program Area

The most common Form 483 observations for drugs, devices, food, biologics and veterinary, ranked by frequency.

Public preview · Intelligence detail

GxP Landscape

A public map of FDA-registered device establishments; SPEQ Intelligence adds filters, named facilities and drill-down.

FDA registrationOpen →

WHAT IS ON THE MARKET, AND WHAT IT IS DOING

Drug Approvals

Every FDA drug application — brand and generic name, sponsor, dosage form and approval history.

Drugs@FDAOpen →

FDA product classificationOpen →

Device Product Codes

Every FDA device product code — class, regulation and specialty, with 510(k)/PMA and recall activity.

openFDA 510(k) · PMA · refreshed weeklyOpen →

Device Clearance Tracker

A public snapshot of 510(k) clearances and PMA approvals; SPEQ Intelligence adds pathway, specialty and trend analysis.

FDA shortages · refreshed dailyOpen →

Drug Shortages

A public snapshot of active FDA drug shortages; SPEQ Intelligence adds availability, therapeutic-area and trend analysis.

openFDA events · refreshed weeklyOpen →

Safety Signals

Adverse-event reporting volumes across FAERS, MAUDE, CAERS and veterinary; SPEQ Intelligence adds term and quality analysis.

fda.gov · refreshed every six hoursOpen →

FDA MedWatch

FDA MedWatch safety alerts and press releases — recalls, market withdrawals and safety communications.

THE REFERENCE SHELF

FDA · EMA · ICH · WHO · ISOOpen →

Standards Library

GxP standards decoded for GMP, GCP, GLP, validation, data integrity and inspection readiness.

Template Library

Templates for SOPs, protocols, validation, risk management, data integrity and inspection readiness.

Tools & Software

Interactive tools for maturity, ICH Q9 risk scoring, Annex 1 gaps and validation scope, plus a software directory.

Toolkits

High-stakes GxP events decoded into phased readiness checklists, with the assets that bear on each.

Public · Professional analysis

FDA QMM

FDA’s QMM program — the five practice areas and how to prepare; Professional maps it to controls and evidence.

FDA CDEROpen →

Quality Economics

Why mature quality pays — the cost-of-quality curve, the cost of poor quality and the ROI of maturity.

FDA · SPEQOpen →

[ LIVE REGULATORY FEED ]LIVE

What's moving in GxP right now.

Composed at request time from the same scheduled ingests the rest of the platform reads — Federal Register documents and FDA enforcement reports — with source provenance attached to every item.

Oct 27, 2026

U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "U.S.-Origin Statements on Seafood." The draft guidance, when finalized, will provide examples of U.S.-origin statements in seafood product l…

Oct 27, 2026

Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow F…

Oct 26, 2026

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers…

Oct 23, 2026

PROPOSED RULEHealth and Human Services Department

Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapte…

Oct 23, 2026

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Oct 23, 2026