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“Facilities using this processing technique to manufacture sterile drug products were a logical starting place because of the significant impacts on patient safety… Read More
Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment. Read More
A California district judge dismissed a class action lawsuit against Rite Aid alleging that the drugstore giant pumped up patient copays for certain generic drugs — but left the door open for an amended complaint. Read More
Drug shortages have increased in both length and intensity over the past year, according to FDA officials who spoke on Tuesday at a public meeting on the issue in Washington, D.C. Read More
The agency may require post-marketing studies to assess serious risks related to a drug’s use, or to identify unexpected serious risks that data suggest could arise. Read More
The suit identifies a child diagnosed with opioid-related neonatal abstinence syndrome at birth in 2010 due to in utero exposure to the drugs. Read More
Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) quizzed Aetna, Anthem and United Healthcare in a Nov. 20 letter on how spending on insulin has changed over the past decade. Read More