Regulatory Affairs

FDA: Guidance on Quality Chewables

The FDA released final guidance on quality attributes sponsors should consider for chewable tablets, suggesting they should be easy to chew, have a “bearable” taste and disintegrate easily. Read More

MHRA: Brexit Won’t Change EU Drug Market Access

UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections. Read More

Senate Passes Bipartisan Opioid Crisis Relief Package

The Senate Monday — by a 99 to 1 margin — passed a bipartisan legislative package targeting the opioid crisis. The move comes on the heels of House passage of its own measure designed to get a handle on prescriptions of and addictions/deaths linked to the potent pain med. Read More