New FDA Regulations Plunged in 2017

Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC).

Despite the slowdown in new regulations, the report found that the agency has not slowed the pace of its issuance of draft and final guidances, according to a review of Federal Register data. “This indicates that while the FDA isn’t issuing new regulations, it’s still using other existing statutory and regulatory authority at a similar pace,” according to PwC.

The report also noted a record-high for generic drug approvals that are the result of long-term efforts within the agency. Each of the last full years saw the FDA approve more generic drugs than the previous year. The 2012 creation of GDUFA was also a major driver of increased generic approvals, as was a series of expirations for patents approved in the late 2000s.