Sunscreens containing an SPF over 30 will be required to use one collective term, "SPF 30 plus" or "SPF 30+" on labeling under FDA's final sunscreen monograph published in the Federal Register May 21. Due to the projected considerable economic burden on sunscreen manufacturers to comply with the regulation, FDA is extending the proposed 12-month compliance deadline to 24 months (for other provisions of the reg, see chart, p. 6).
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.
The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.
Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.
