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The FDA is weighing changes to biologics regulations that would get rid of required tests for mycoplasma in vaccines—a change the agency believes will help encourage innovation. Read More
Australia’s Therapeutic Goods Administration on Monday issued guidance to help sponsors comply with “minimum” drug quality requirements under a new standard that went into effect on March 31. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance for EU drugmakers shipping medicines by air freight to the UK in the event of a no Brexit agreement. Read More
The FDA released a final guidance on pediatric labeling of prescription drugs that, among other recommendations, calls for black box warnings on medicines with inactive ingredients that might be dangerous to babies and children. Read More
Some Australian drugmakers are still figuring out how to pass muster during the Therapeutic Goods Administration (TGA)’s new pharmacovigilance inspections introduced in 2017, according to the TGA’s first metrics report. Read More
CDER plans to release 93 new or revised guidances for drugmakers in 2019, including more than a dozen on drug quality and chemistry, manufacturing and controls. Read More