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India’s drug regulators are drafting new rules that would classify drugs with new formulations and delivery mechanics as “new drugs” — a move that would require drugmakers to conduct additional trials before selling the products. Read More
The FDA has lifted a partial clinical hold on Cell Therapeutics’ blood cancer drug tosedostat, giving the green light for continuing mid-stage clinical trials. Read More
A newly introduced House bill would legalize the personal importation of prescription drugs nationally, following a Maine law enacted in 2013 that is currently facing a legal challenge brought by the pharmaceutical industry. Read More
The FDA and the World Health Organization (WHO) are considering placing new restrictions on 26 popular painkillers, including the widely used tramadol and tapentadol. Read More
Takeda is ending all trials of its type 2 diabetes drug fasiglifam after determining that the drug’s benefits were outweighed by liver risks. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More
The FDA plans to standardize electronic drug applications and other regulatory submissions over the next five years and will release a host of guidances in 2014 and 2015 to implement the standardization. Read More
French authorities have fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More