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The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final guidances, the agency urges drug sponsors to focus on real-world settings when trying to determine doses. Read More
The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More
The FDA issued final guidance on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More
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
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
Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Read More
The European Medicines Agency said it needs to scale back or suspend more activities, blaming Brexit for staff reductions that are disrupting its ability to function. Read More
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
The European Medicines Agency (EMA) is considering revisions to its guidance for sponsors of medicines for neonates and is seeking input from stakeholders by Dec. 16. Read More