We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
UK lawmakers on Friday failed to approve an orderly withdrawal from the European Union, leaving drugmakers and regulators scrambling to make sense of the chaos. Read More