We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The National Association of Medicaid Directors called the decision “disappointing for Massachusetts and for a lot of other states that really want to do something similar.” Read More
The video “fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” the agency said. Read More
The regulations allow pharmaceutical manufacturers to request that information they submit to the department be considered trade secrets and kept confidential. Read More
PhRMA, the Biotechnology Innovation Organization (BIO) and the State of Nevada agreed to dismiss a case regarding the constitutionality of a Nevada drug pricing law that required companies to disclose confidential business information. Read More
A former drug distributor filed a class action lawsuit against Novartis and Par Pharmaceuticals Friday, accusing the drugmakers of a pay-for-delay scheme to block generic competition for Novartis’ blood pressure drug Exforge (amlodipine and valsartan). Read More
The FDA’s Office of Prescription Drug Promotion issued an untitled letter to Pfizer for a misleading direct-to-consumer online video for its Estring (estradiol vaginal ring) treatment for moderate-to-severe painful sex and vaginal discomfort after menopause. Read More
The Federal Trade Commission is taking a victory lap after a federal judge ordered AbbVie to pay a record $448 million antitrust award over its handling of a testosterone replacement gel. Read More
CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More