A Michigan clinic manager pleaded guilty to a scheme to unnecessarily prescribe controlled substances that lost Medicare $131 million, and Attorney General Jeff Sessions called the plea the latest victory…
The FDA hit BODE Chemie with a Form 483 for failing to follow proper quality control procedures, in addition to other deficiencies at its facility in Hamburg, Germany. Source: Drug…
Federal right-to-try legislation passed in the Senate and now awaiting a vote in the House would only minimally benefit patient access to investigational drugs and would delay the FDA’s approval…
The Federal Trade Commission took CellMark Biopharma to federal court for falsely advertising two of its supplements as “clinically proven” to treat cancer and cancer treatment side effects. Source: Drug…
A new CDER-funded study says the FDA is not taking full advantage of social media to communicate drug safety information — and should, for example, be making more use of…
The FDA will prioritize the opioid crisis, innovation, and generic competition in the coming year, the agency said in a 2018 Strategic Policy Roadmap released Thursday. Source: Drug Industry Daily
The European Medicines Agency updated guidance on clinical investigations of rheumatoid arthritis drugs to add new endpoints and distinguish between patient subgroups in trials. Source: Drug Industry Daily
Three South Dakota tribes sued two dozen drugmakers including Allergan, Teva and Purdue alleging the companies violated the Racketeer Influenced and Corrupt Organizations (RICO) act and engaged in fraud and…
CDER achieved numerous firsts in its past year of drug approvals, covering treatments for several rare diseases, cancer therapies and antibiotics. Source: Drug Industry Daily
The House Energy and Commerce Committee released a review of the 340B drug discount pricing program, identifying weaknesses in oversight and administration, among other issues, and offering recommendations to resolve…