Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
For an agency that has announced its intention to release more than 100 draft guidance documents in 2017, the US Food and Drug Administration (FDA) is off to a slow start following President Donald Trump’s inauguration.
In the nearly three months since 20 January, FDA has only released two draft guidance documents and four final guidances.
And all six of those documents were either slight tweaks to previously issued guidance, updates to expiration dates of older guidance or guidance from the International Council for Harmonisation (ICH) released for consultation.
Those six also compare with a flood of 37 draft and final documents released in the final three months before Trump took office, perhaps revealing an agency that was trying to wrap up its work under outgoing commissioner Robert Califf.
So why has FDA been slow to issue guidance (and other notices and rulemakings in the Federal Register) under the Trump administration in 2017? Has Trump’s “two out, one in” executive order impacted the release of guidance? Or is a lack of a Senate-confirmed FDA commissioner keeping the agency from moving forward?
The answers remain unclear. FDA referred Focus questions on the matter to the White House, which referred Focus to the Department of Health and Human Services and the Office of Management and Budget, which did not respond to questions.
But back in early January, when 17 draft and final guidances were released just before the inauguration, an FDA spokesperson explained to Focus that FDA’s issuance of guidances is done in accordance with its mission to protect the public heath.
And perhaps once Scott Gottlieb wins confirmation as the next FDA commissioner, the agency will speed up its guidance release pace.
Rachel Sachs, an associate professor of law at Washington University in St. Louis, told Focus: “I think they're waiting for Gottlieb to set his priorities, and they'll move forward then. The other thing I'll say is that they've been busy behind the scenes on things like the -UFAs [user fee agreements], so I wouldn't be surprised if a lot of time has gone into that.”
Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017
Tags: FDA guidance documents, OMB, draft guidance pharmaceuticals