FDA Commissioner Scott Gottlieb Tuesday expressed FDA’s commitment to advancing the use of real world evidence, defended the idea that data from clinical experience should be incorporated into regulatory decisions, and acknowledged that the agency won’t have the last word when it comes to interpreting real world evidence. Speaking at a National Academy of Sciences workshop on RWE, Gottlieb took on critics who say FDA should only consider data from randomized, controlled trials.
FDA’s description of Kymriah tisagenlecleucel from Novartis AG as the “first gene therapy” approved in the U.S. provoked a debate about taxonomy that distracted from an important regulatory decision. What matters is that FDA has decided certain gene therapies can be eligible for the Regenerative Medicine Advanced Therapy (RMAT) designation. Defining CAR T as gene therapy means they could qualify for RMAT designation, potentially speeding their development.
FDA Commissioner Scott Gottlieb Tuesday announced that the agency will close a “loophole” in its implementation of the Orphan Drug Act that drug companies have used to avoid conducting pediatric studies. “This circumstance arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease,” he said in a blog post.
Muck Rack makes it simple to find people, tweets, or articles that mention any name, keyword, company, hashtag etc. We've compiled this guide to help you make the most of your search.
Selecting a term
Start searching tweets, articles from media outlets, articles mentioned in tweets, journalists'
names, titles and bios with some suggested searches:
Companies or Topics (e.g. iPhone, Microsoft)
Phrases (e.g. "cloud computing") — use quotes to keep the terms together
Twitter handles (e.g. @username) — returns those who have mentioned or replied to
Names (e.g. "David Pogue")
Hashtags (e.g. #sxsw, #london2012)
Bio details (e.g. vegan, Olympics, father)
Muck Rack's Advanced Search allows for many boolean operators.
Find results that mention multiple specified terms, use AND or
+. For example, ensure each result contains both Elon Musk and Mark Zuckerberg by
searching Obama AND Romney or Obama + Romney.
Use the operators OR or , to broaden your search when you'd like either of
multiple terms to appear in results. (This is the default behavior of our search when no operators
are used.) For example, search for democrat OR republican to find results that refer to
Democrats and/or Republicans.
Use NOT or - to subtract results from your search. For
example, searching Disney will yield results about the Walt Disney Company as well as Walt Disney
World Resort. To exclude mentions of Disney World, search for Disney -World or Disney
When using one of these operators with a phrase, enclose it in quotation marks. For example, you can
find results about smartphones excluding Apple's iPhone 4S by searching smartphone -"iPhone
Exact case matching or punctuation
If you're searching for a brand name or keyword that relies on specific punctuation marks or capitalization, you can
find results that match your exact query by adding matchcase: before the keyword you're searching for, like matchcase:E*TRADE .
Use parentheses to separate multiple
boolean phrases. For example, to find journalists talking about having fun in Disney World or
Disneyland, search for ("disney world" OR disneyland) AND fun.
An asterisk can be used to search for any variation of a root word truncated by the asterisk. For example, searching for admin* will return results for administrator, administration, administer, administered, etc.
A near operator is an AND operator where you can control the distance between the words. You can vary the distance the near operation uses by adding a forward slash and number (between 0-99) such as strawberries NEAR/10 "whipped cream", which means the strawberries must exist within 10 words of "whipped cream".