The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the hopes of lowering drug prices.

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions of complex biologic medicines, aiming to lower the cost of treatments for ...

FDA plans to ease biosimilar study requirements, cutting development costs by ~$20M and boosting competition for costly biologics.

The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic medications in a bid to bring more competition to the market and lower ...

The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...

The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.

The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...

The FDA is planning to only ask for one pivotal clinical trial instead of the long standard of two trials for drug approval. The present FDA commissioner believes it carries the same statistical power ...

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...

Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...