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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
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
The generics industry enters uncharted territory in 2014 as it adjusts to a landscape altered by monumental Supreme Court rulings in 2013 and the FDA’s proposed rule to authorize generic drugmakers, for the first time, to change product labeling in response to safety signals. Here’s an overview of the significant events that happened in 2013 and how they promise to shape the industry in 2014 and beyond. Read More
HHS has approved the overhaul of the FDA’s Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More
The FDA has rejected Sanofi’s plans for an expanded indication in relapsing multiple sclerosis for its drug Lemtrada, the second pipeline setback for the company since November. 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
The FDA does not intend to prevent compounders from making preterm birth drug Makena, the agency says in a legal filing outlining how it intends to approach one contentious issue involving compounders. Read More