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The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
The FDA said its Center for Drug Evaluation and Research and the Office of Prescription Drug Promotion issued 47 warning letters last year, compared with 52 in 2014. Read More
A bill calling for a new generic priority review voucher that was introduced by Sen. Susan Collins (R-Maine) would aim to speed patient access and keep drug prices in check by creating more generic competition. Read More
Amid the backdrop of the national opioid epidemic, Endo Pharmaceuticals has settled false advertising allegations concerning its promotion of the painkiller Opana ER, according to the New York Attorney General’s Office. Read More
Drugmakers submitting anonymous clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Read More
The FDA’s regulations for drug promotions desperately need to be updated as they are unlikely to survive future court challenges, industry experts say. Read More