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European drugmakers will be allowed to make generics and biosimilars after the European Parliament voted in favor of manufacturing waivers that will allow their export. Read More
Four U.S. drug manufacturers were handed Form 483s for quality violations observed at their facilities, such as issues with quality monitoring, facility maintenance and unqualified handling of quality responsibilities. Read More
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Read More
A trade group representing combination drug products is urging the FDA to draw bright lines among the agency’s centers as it considers voluntary quality standards. 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 hammered five drug manufacturers — one Indian and four American — for varying issues at their drug making facilities, sending the companies Form 483s for their violations. Read More
Five American drugmakers were hit with warning letters after the FDA discovered an assortment of issues at their facilities, including contamination risks, missing procedures and issues with cleaning. 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