Category Archives: FDA Policy

New Drug Approvals – A Mid-Year Assessment

During the past few years, there has been a renewed focus on facilitating the development of new medicines by providing new mechanisms to streamline the review process and get drugs to patients more quickly. The passage of the 21st Century … Continue reading

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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