The Competitive Generic Therapy designation looks to encourage the development of alternatives for drugs with inadequate generic competition. The Food and Drug Administration on Wednesday approved a ...

So you’re preparing an abbreviated new drug application submission… what could possibly go wrong? The Food and Drug Administration responds: Let us count the ways… However, much of it can be avoided ...

The Food and Drug Administration has accepted Lannett’s abbreviated new drug application for fluticasone propionate and salmeterol inhalation powder in three strengths — a generic of GlaxoSmithKline's ...

Consumers and lawmakers pushing for cheaper alternatives to the EpiPen, an antidote for life-threatening allergic reactions, and other high-priced drugs are seeking answers about a stubborn backlog of ...

The Federal Circuit’s holding emphasizes the importance of including an inventive concept in future applications of machine learning if an inventor wishes to obtain or enforce a patent. As the Federal ...

For the first time since 2012, ICANN — the organization that coordinates the global domain name system — has opened a new ...

The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, established a pathway for the approval of generic drugs. Under this act, manufacturers ...

Two years ago, the FDA was authorized to start collecting fees from generic drug makers in order to fund two key goals – increase the number of facilities to be inspected, especially overseas, and ...

The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one ...

Now that the Food and Drug Administration plans to fast-track generic drug applications in hopes of spurring competition and lowering medicines costs, a key question should be asked: Can the agency ...