EMA
EMA opens consultation on gastrointestinal interaction guideline
EMA published a draft scientific guideline on investigating interactions in the gastrointestinal tract. The consultation is open.
Read the official sourceMHRA
MHRA updates UK ATMP licensing guidance
MHRA published guidance on obtaining a marketing authorisation for an advanced therapy medicinal product sold or supplied in the United Kingdom.
Read the official sourceMHRA
MHRA updates exceptional use authorisations for medical devices
MHRA published its list of manufacturers and devices granted exemptions, including exemptions that expired or were cancelled.
Read the official sourceMHRA
MHRA publishes UK orphan product list
MHRA published a list of authorised orphan medicinal products registered by the UK licensing authority.
Read the official sourceFDA
FDA submits customer satisfaction survey collection for OMB review
FDA announced that its proposed customer and partner customer service satisfaction survey collection was submitted to OMB for review and clearance under the Paperwork Reduction Act.
Read the official sourceWhy this matters
The EMA consultation gives regulatory teams an opportunity to review a developing scientific framework for gastrointestinal interaction studies. The MHRA publications provide current reference points for UK advanced therapies, device exemptions and orphan products, while FDA's notice documents an administrative information collection review.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.