Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 029

Safety actions and procedural updates lead the regulatory agenda

Today’s official updates span European safety monitoring, UK licensing and recalls, and FDA administrative actions affecting biologics, expanded access and generic drugs.

By Scott Morvay, Founder October 12, 2026 Official sources linked

EMA

EMA communicates new Ocrevus liver injury risk

A direct healthcare professional communication identifies a new risk of drug-induced liver injury and provides recommendations for liver function monitoring before and during treatment.

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EMA

EMA adopts revised PIP compliance Q&A

EMA adopted revision 3 of its questions and answers on PIP compliance verification and paediatric rewards.

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MHRA

MHRA updates International Recognition Procedure guidance

MHRA updated its guidance on using the International Recognition Procedure for medicines licensing applications.

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MHRA

MHRA issues Class 2 recall for Pedmarqsi batches

Norgine Pharmaceuticals is recalling listed batches of Pedmarqsi 80 mg/mL solution for infusion because routine stability investigations identified a risk of particulate matter.

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FDA

FDA sends BLA information collection for OMB review

FDA submitted its proposed information collection covering biologics license application procedures and requirements to OMB for review and clearance.

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FDA

Expanded access information collection reaches OMB

FDA submitted its proposed information collection for expanded access to investigational drugs for treatment use to OMB for review and clearance.

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FDA

FDA corrects earlier ANDA withdrawal notice

FDA removed three Navinta applications from a prior withdrawal notice because the company had timely requested that their approvals not be withdrawn. The approvals remain in effect.

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Why this matters

Regulatory teams should note the updated European safety and paediatric guidance, check the current UK recognition procedure, and verify affected products and application records. The FDA notices also provide visibility into administrative requirements and confirm the status of three ANDAs.

Scott Morvay

Founder, Gulfstream Intelligence

This brief provides general regulatory news and educational information. It is not legal or regulatory advice.