Category Archives: FDA Policy

Speaking of Communications – OPDP on the Move

Over the past few years, regulatory action letters from FDA’s Office of Prescription Drug Promotion (OPDP), while once plentiful, has been something of a rare occurrence. In response to questions on the matter, FDA was often vague. This week however, … Continue reading

Posted in FDA Policy, Warning Letters | 2 Comments

HHS Proposes Pricing in DTC

In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list … Continue reading

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Mid-Year Check on the Pace of New Drug Approvals at FDA

At the mid-year point, I usually do a check-in to see how we are doing on new drug approvals and how it compares to years gone by. I am quite tardy checking in on that front, so let’s get it … Continue reading

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What They Said – FDA Press Releases 2d Quarter 2018

A personal note – Apologies – I have been lagging on postings following a bereavement.  As each quarter ends, it has been an Eye on FDA practice to look back and compare different types of activities to assess any changes … Continue reading

Posted in FDA Image, FDA Policy | 2 Comments

A (Slight) Liberalization of Communications with Docs from FDA

What Happened. This week FDA issued a new final guidance related to communications about medical products that, while representing a slight liberalization of regulation when it comes to discussing useful information about a drug and the cleared uses for it, … Continue reading

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