Expiration dates on tubes: Expiration dating placed on the crimp of a dispensing tube "is an acceptable way to comply" with current regs, FDA tells Bob Nakutin, Westport, Wash., in an April 22 response to his citizen petition. The petition requests that the expiration date be placed in a "more visible location" -- consumers often roll up tubes, rendering the date invisible -- and that it be "made easily legible" through the use of contrasting colors. FDA responded that "no known problems have been associated with such information appearing on the crimp of the dispensing tube," and it has "not encountered any [dates] that are unreadable due to lack of color contrast"...
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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.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
