News Intelligence

Regulatory news monitoring across FDA, EMA, Health Canada, PMDA, USP, and ICH. Event-driven briefs that cover what changed, what agency said it, when it happened, and what it implies for your pipeline — dated and cited, not aggregated summaries.

Coverage

• FDA Advisory Committee (AdCom): meeting agendas, briefing documents, voting outcomes, post-meeting FDA decisions.
• EMA CHMP: monthly meeting highlights, opinions, recommendations for marketing authorization.
• Health Canada: advisory notices, notifiable changes, patent register decisions.
• PMDA: council decisions, PSE (Pharmaceutical and Food Safety Bureau) announcements, reexamination outcomes.
• USP: Pharmacopeial Forum stakeholder proposals, general chapter updates, reference standard releases.
• ICH: expert working group document releases, revision cycles, regional implementation timing.
• FDA guidance dockets: draft and final guidance publications, comment period deadlines.

What each brief contains

• Event title, agency, date, meeting / docket reference.
• Summary of what was decided or announced (dated citations).
• Named molecules / sponsors / indications affected.
• Implication scoring: 1-5 scale, with rationale.
• Direct URL to source document with access date.

Scoping

News Intelligence can be scoped by:

• Therapeutic area (oncology, cardiometabolic, CNS, rare disease, infectious disease).
• Drug class or mechanism.
• Regulatory pathway: 505(b)(1), 505(b)(2), biosimilar, generic ANDA / ANDS, medical device, orphan.
• Competitor sponsor.
• Specific molecule or INN.

What it does NOT do

• It does not substitute for a paid pipeline database (Citeline, Cortellis). It is event-driven, not a continuously curated registry.
• It does not publish commentary under fictitious author names. Briefs are signed by role ("Regulatory Intelligence Analyst") rather than invented personal names.
• It does not make pricing decisions or recommendations in non-USD currency.

Frequently asked questions