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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
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
2014 will look a lot like 2013 for the pharma industry, analysts say, with patent expirations and cost-containment policies, especially in the EU, depressing revenue growth. Read More
Sponsors of drugs with salt-based active ingredients are urged to follow the United States Pharmacopeia’s (USP) strict naming rules for such drugs, but the FDA may make an exception when the name of the salt contains “vital information” for clinical use, new draft guidance states. Read More
Hot on the heels of Amgen’s state-level campaign to limit dispensation of biosimilars, the biotech is voicing strong opposition to plans by the FDA to allow biosimilars to share the same international non-proprietary name (INN) as the biologic they reference, calling for unique INNs. Read More