Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA is cracking down on companies that manufacture or distribute unapproved prescription ear drops labeled to relieve pain, infection and inflammation, warning they will be subject to seizures, injunctions and criminal proceedings. Read More
The FDA is investigating the potential risks of medicines containing codeine to treat coughs and colds in children 18 and younger because of the potential for serious side effects, according to a safety announcement released Wednesday. Read More
Democratic members of the House Energy & Commerce Committee are pressing the FDA to expand the black box warning on extended-release opioids to include immediate-release versions of the painkillers as well. Read More
Mylan is expanding its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests. Read More