As UK Prime Min­is­ter There­sa May’s Brex­it deal is ex­pect­ed to be re­ject­ed Tues­day in a House of Com­mons vote, the EMA has said that af­ter close­ly mon­i­tor­ing staffers’ in­ten­tions to re­lo­cate to Am­s­ter­dam, it cur­rent­ly ex­pects a staff loss of about 25%.

The 25% fig­ure might seem like a lot of staffers to lose (about 225 of 900 lost), but that fig­ure is on the low end of pre­dic­tions from a sur­vey in Sep­tem­ber 2017 that found EMA ex­pect­ed to lose at least 19% of its staffers no mat­ter which city was se­lect­ed.

In ad­di­tion to the staffing loss­es, EMA said it will fur­ther tem­porar­i­ly re­duce or sus­pend ac­tiv­i­ties in the first half of 2019 as it moves in­to the fi­nal phase of its phys­i­cal re­lo­ca­tion. EMA said it will launch such mea­sures as part of a fourth and fi­nal phase of the busi­ness con­ti­nu­ity plan as of 1 Jan­u­ary.

For in­stance, be­tween 11 Feb­ru­ary and 15 March 2019, no pre-sub­mis­sion meet­ings for ini­tial mar­ket­ing au­tho­riza­tion ap­pli­ca­tions will take place, while EMA moves to its new premis­es. EMA will al­so not print or dis­patch cer­tifi­cates for phar­ma­ceu­ti­cal prod­ucts from 25 Feb­ru­ary un­til 14 March 2019, though com­pa­nies can still sub­mit re­quests dur­ing this pe­ri­od, which EMA will con­tin­ue to process.

“Tem­po­rary sus­pen­sion and scal­ing back of ac­tiv­i­ties is cur­rent­ly sched­uled to last un­til 30 June 2019. Cur­rent staffing pro­jec­tions should al­low EMA to grad­u­al­ly re­sume these ac­tiv­i­ties as of Ju­ly 2019. EMA will re­view this in April 2019, once it has moved to its tem­po­rary build­ing in Am­s­ter­dam,” EMA said.

And staff re­lo­ca­tion to the per­ma­nent build­ing is slat­ed to be fi­nal­ized by 31 De­cem­ber 2019.

The agency said that de­spite the halt­ing of cer­tain ac­tiv­i­ties, it ex­pects all core ac­tiv­i­ties re­lat­ed to the eval­u­a­tion and su­per­vi­sion of med­i­cines “to con­tin­ue with­out any in­ter­rup­tion or de­lays fore­seen and to the same qual­i­ty.”

The agency al­so said it will pro­vide more in­for­ma­tion on this fourth phase of the con­ti­nu­ity plan and its ac­tiv­i­ties dur­ing this crit­i­cal pe­ri­od short­ly.

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.