John Kamp

Most recent articles by John Kamp

Clinton or Trump? Either Way, Change Is Coming
Clinton or Trump? Either Way, Change Is Coming
John Kamp
July 6, 2016
1:00 pm

Donald Trump and Hillary Clinton offer clear contrasts on the issues of the Affordable Care Act, entitlement reform, and drug pricing.

2016 May Bring More Warning Letters, Guidance from FDA
2016 May Bring More Warning Letters, Guidance from FDA
John Kamp
January 12, 2016
12:00 pm

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

21st Century Cures, Amarin Court Case Advance
21st Century Cures, Amarin Court Case Advance
John Kamp
July 13, 2015
3:15 pm

Pharma’s efforts to evolve restrictions about off-label marketing move forward.

Washington Insider: John Kamp
Washington Insider: John Kamp
John Kamp
February 27, 2015
12:00 pm

The FDA must address its policies to accommodate the new medical and media environment

Off-label on the table
Off-label on the table
John Kamp
May 1, 2013
4:00 am

FDA cannot rely solely on the label or the current standard for drug approvals

As I See It: Life under the “Sunshine Act”
As I See It: Life under the “Sunshine Act”
John Kamp
March 1, 2013
5:00 am

While we all like the sun, life under the final rules for the “Sunshine Act” provisions of the Affordable Care Act is going to be complicated and treacherous for drug companies and their agencies.

WEB EXCLUSIVE: Pharmas must step up and lead on off-label, online communications
WEB EXCLUSIVE: Pharmas must step up and lead on off-label, online communications
John Kamp
January 3, 2012
8:30 pm

FDA’s recent draft guidance on off-label communication is, despite its shortcomings, a step forward, writes John Kamp, arguing that pharmas should take this welcome bit of clarity and act boldly on it

As I see it
As I see it
John Kamp
August 16, 2010
6:18 pm

Over 30 years ago a gregarious Congressman from Louisiana gave me and others some off-the-record advice on how to succeed on Capitol Hill.

As I see it: DDMAC elevated to OPDP
As I see it: DDMAC elevated to OPDP
John Kamp
March 15, 2010
9:04 pm

If you or your clients have sent promotion materials to FDA recently for pre-publication review, or–God forbid–have been the recipient of a DDMAC Warning Letter, you know that FDA’s DDMAC has assumed a very aggressive enforcement posture.

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