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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
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
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
Newly confirmed FDA Commissioner Robert Califf sought to quell concerns about the FDA’s response to the opioid epidemic at a Senate hearing on the FDA’s $5.1 billion budget request for fiscal 2017. Read More