Record New FDA Approvals in 2015, But is That a Guarantee?

According to a recent FDA report, their Center for Drug Evaluation and Research (CDER) approved 45 novel drugs in calendar year 2015. These drugs fell into one of three categories: New Molecular Entities, New Drug Applications, and New Therapeutic Biologics. This year, CDER also approved more “orphan” drugs for rare diseases than they have in any previous year.

While CDER approves hundreds of new medications each year, most are variants of previous existing products. These can include new dosage forms or generic formulations of drugs that have already undergone approval. Novel drugs—new and genuinely innovative drug products—typically make up only a small number of total annual approvals.

CDER approved a higher than average number of novel drugs in 2015. However, the number of applications for these drugs that sponsors have submitted over time has remained relatively stable. The agency notes that these approvals represent products that “serve previously unmet medical needs or otherwise significantly help to advance patient care and public health.” They go on to stress that these products present patients in need with access to new and innovative therapies.

Even though this is a record year for novel drug approvals; it is important to note that the FDA approval process has in no way become quicker, easier, or less complicated. The FDA and CDER still rely on a number of regulatory tools to help ensure the safe and efficient development of a novel drug before it can gain final approval—and they continue to make an ever-increasing number of changes to their regulatory requirements every year. For this reason, it remains as important as ever to keep pace with the current regulatory and approval landscape.

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