Gulfstream Daily Brief

The regulatory news that deserves your attention.

A concise weekday briefing for regulatory affairs professionals in pharma and biotech, focused on the United States, Europe, and ICH.

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Latest briefIssue 033October 16, 2026

FDA advances eCTD implementation and rare disease framework discussions, EMA opens herbal interaction consultation

Electronic submission standards lead today’s brief, alongside opportunities to inform emerging approaches to rare disease therapies and herbal medicinal product interactions.

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Issue 033October 16, 2026

FDA advances eCTD implementation and rare disease framework discussions, EMA opens herbal interaction consultation

FDA announced new eCTD validation rejections, eCTD 4.0 forward compatibility, and a rare disease meeting. EMA opened consultation on herbal drug interactions.

The regulatory news that deserves your attention.

Start your day informed.

FDA advances eCTD implementation and rare disease framework discussions, EMA opens herbal interaction consultation

All editions

FDA advances eCTD implementation and rare disease framework discussions, EMA opens herbal interaction consultation

FDA authorizes four emergency animal drugs and updates feed additive rules

FDA renews cell and gene therapy advisory committee, EMA posts revised VICH testing guideline

FDA finalizes biosimilar manufacturing guidance, EMA opens retinal dystrophy consultation

Safety actions and procedural updates lead the regulatory agenda

FDA sets three Class II device pathways, EMA opens nasal product consultation

FDA opens comment period as UK regulators update medicines oversight

FDA corrects Orange Book and ANDA records, EMA updates procedural guidance

FDA seeks input on ibogaine trials as US and UK device policy advances

MHRA issues precautionary recall and updates medicines guidance

MHRA updates UK licensing guidance as FDA advances program review

FDA committee actions and MHRA guidance updates

MHRA updates MRI safety guidance, export restrictions, and September safety communications

FDA addresses drug approvals and information collection, MHRA updates device guidance

MHRA updates medicines guidance as FDA issues debarment orders

FDA opens biosimilar fee talks as US and EU guidance moves forward

FDA seeks input on islet therapies, EMA and MHRA issue updates

FDA issues final debarment order, MHRA posts safety and performance updates

FDA updates nonclinical terminology as EMA adopts ICH M13B

FDA opens year five of CMC pilot as EMA advances new guidance

FDA advances biosimilar and submission guidance as MHRA opens fees consultation

FDA finalizes device exemption decision, blood systems guidance, while EMA and MHRA update key resources

FDA opens sequencing discussion, MHRA seeks views on AI safety

FDA opens rare disease statistics docket, European regulators update safety and application information

EMA opens GI interaction guideline consultation, MHRA updates key regulatory lists

FDA acts on sunscreen ingredients and device classifications, EMA opens neurology consultation

FDA sets FY 2027 voucher fee framework, EMA adopts revised inspection guidance

FDA issues neonatal nutrition compounding guidance and opens public comment opportunities

EMA updates procedural guidance on GMP inspection coordination

FDA opens botanical drug docket, MHRA and EMA publish regulatory resources

FDA finalizes device and veterinary guidance as EMA updates centralized procedure advice

Evidence standards move, and market status can move with them