Author Archives: Mark Senak

An Overview of FDA OPDP Enforcement for 2019

It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between the time a letter is sent and the time it is … Continue reading

Posted in Warning Letters | Tagged , , | Comments Off on An Overview of FDA OPDP Enforcement for 2019

The Growing Profile and Influence of ICER

The year began with a prediction from Senator Mitt Romney to pharmaceutical executives that “change is coming”. There have been high profile hearings on the topic in the Congress and legislation that moved in both the Senate and the House … Continue reading

Posted in Pharma Industry Image, Pricing and Value | Tagged , , | Comments Off on The Growing Profile and Influence of ICER

What They Said – A Look at Press Releases Issued by FDA in 2019

It is time to look at the forest rather than the trees. It has been a regular custom to occasionally look back and see what FDA has been saying, and how frequently the agency has been saying it and what … Continue reading

Posted in FDA Image, News | Tagged | Comments Off on What They Said – A Look at Press Releases Issued by FDA in 2019

2020 Vision – Notable FDA Actions During 2019

Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a … Continue reading

Posted in FDA Image, FDA Policy | Tagged , , , | Comments Off on 2020 Vision – Notable FDA Actions During 2019

Remaining Aloof from Politics

Yesterday FDA issued a press release regarding the much-anticipated actions related to the importation of prescription drugs. It is the aim that a proposed rule and a draft guidance will provide two means of impacting the price of medicines through … Continue reading

Posted in Uncategorized | Comments Off on Remaining Aloof from Politics