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Australia’s Therapeutic Goods Administration updated its plan for mandatory drug shortage reporting based on public comments in response to an April request. Read More
HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials for six months until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period. Read More
The European Medicines Agency launched its new online portal for orphan designation applications and is strongly encouraging companies to start using the portal right away, although it will not fully replace the existing submission process until the fall. Read More
The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Read More
The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a report released Tuesday. Read More
The FDA on Tuesday announced that it will strengthen current warnings in the prescribing information for fluoroquinolone antibiotics regarding potential mental health side effects and blood sugar disturbances. Read More
For severely unwell patients or those with a higher risk of resistance, NICE recommends using either co-amoxiclav, levofloxacin, moxifloxacin or co-trimoxazole as alternative treatments. Read More