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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 released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections. 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Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention.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 FDA approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution. Read More
Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency said in a new draft guidance. Read More
AstraZeneca filed suit against generic manufacturer Accord Pharmaceuticals for alleged infringement upon four patents for AstraZeneca’s breast cancer drug Faslodex (fulvestrant). Read More