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The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions.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
The senator is concerned that GSK “did not appear to prepare contingency plans to ensure that sufficient supplies would be available for all patients who fall within the CDC’s recommended guidelines.” Read More
The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil). Read More
FDA officials will work with medical societies to come up with opioid-prescribing guidelines that regulators hope will strike a balance between the needs of chronic pain suffering and the need to protect people from addiction, Commissioner Scott Gottlieb said Monday. Read More
Although the jury took AbbVie’s side in October regarding the claim of strict liability, it also found that the company was negligent and falsely represented the safety and effectiveness of AndroGel. Read More