Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to…
The FDA issued Form 483s to U.S. and foreign drugmakers, citing violations for sanitation issues, unreliable data and nonconformances, among other observations. Source: Drug GMP Report
Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance. Source:…
The FDA slapped three drug manufacturers — including two Chinese firms — with warning letters after the agency’s inspections revealed a wide range of issues at the facilities, such as…
The FDA announced that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Source: Drug GMP…
Endo Pharmaceuticals has settled with the state of Texas for $13.25 million over allegations of illegal marketing for its drug Lidoderm (lidocaine). Source: Drug Industry Daily
In response to investor concern, the board of Cardinal Health announced on Thursday action it has taken to strengthen its anti-diversion tactics and accountability related to the opioid crisis. Source:…
Allergan opened a new front in the intensifying legal fight over the opioid crisis, suing Pfizer last week to cover any damages the former might incur in hundreds of lawsuits…
The House Energy and Commerce Committee this week sent letters to three major pharmaceutical manufacturers demanding information on the role they may have played in helping trigger the opioid epidemic.…
Swiss Medic will overhaul the way it issues export certificates and manufacturing certificates for devices in the fall and introduce new fees that take effect on Jan. 1, 2019. Source:…