The World Health Organization released draft guidelines advising regulators to test the wastewater of drug plants to keep antibiotics out of the environment—and it says wastewater treatment should be part…
Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators on April 3. Source: Drug GMP Report
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. Source: Drug GMP Report
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. Source:…
The FDA issued warning letters to four drugmakers for various GMP violations at their facilities, including quality unit shortcomings. Source: Drug GMP Report
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Source: Drug…
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. Source: Drug GMP Report
The FDA is scrapping requirements that biologics be inspected at least every two years, moving instead to a risk-based schedule. Source: Drug GMP Report
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.…
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. Source:…