Kellie Combs

Partner @ Ropes & Gray, advising on FDA regulatory and compliance issues. Views expressed are my own, not those of R&G or our clients. RTs are not endorsements.

[Laura Helbling @Laura_H]

Full FDA announcement on regen medicine framework: https://t.co/YmU1Pw6Vdz https://t.co/dc2dvx2IXN

[Kellie Combs @kellie_combs]

CA enacts bill on drug pricing transparency. See R&G's analysis here: https://t.co/R3l1Qgr9M1

[Regulatory Affairs Professionals Society @RAPSorg]

REMS Format and Content: @US_FDA Offers Draft Guidance | #Regulatory Focus https://t.co/6HAmf4iQXs #FDA

[Kellie Combs @kellie_combs]

New study on DTC suggests emphasis on serious risks better than listing all risks: https://t.co/VQg6ciiWkj

[Jeff Overley @JeffOverley]

From a new warning letter: The FDA does not find hippie-dippie granola labeling to be charming https://t.co/VLnHtbR5Xv

[Kellie Combs @kellie_combs]

See R&G's summary of the #FDARA legislation here: https://t.co/WoRt0XhLME

[Kellie Combs @kellie_combs]

NIH updates https://t.co/80wYfpPXjH to provide info on protocol submission and other requirements under new rule: https://t.co/nqHcXIeZW4

[John Kamp @rxvoice]

How will this Congress approach medical marketing issues? https://t.co/MCKs29rJJG

[Kellie Combs @kellie_combs]

Big news this morning. #FDA delays effective date of intended use rule until March 2018 and reopens comment period: https://t.co/ZVrK1T9dKv

[Tom Burton @TomBurtonWSJ]

President Donald Trump to nominate Scott Gottlieb to lead FDA . My @WSJ story https://t.co/1WS8MJ8NcS

[Bloomberg @business]

Trump sends pharma stocks tumbling with new tweet on drug prices https://t.co/YGy2R7Pb4O

[Andy Biotech @AndyBiotech]

FDA CDER 2016 Update for Rare Diseases
https://t.co/O1Cx8NXds8

Nice slide deck from Dr. Richard Moscicki

[Matthew Herper @matthewherper]

An FDA reform agenda: What would Commissioner Scott Gottlieb do in his first six months? https://t.co/hKCDFQM7Gl

[John Kamp @rxvoice]

Pharma industry shuns Trump push for radical shift at FDA https://t.co/uR3p00hEZS via @Reuters

[Kellie Combs @kellie_combs]

China #FDA amends med device recall rules. See R&G analysis here: https://t.co/aLHi4HIxzN

[Zach Brennan @ZacharyBrennan]

.@ChuckGrassley Opens Inquiry Into Orphan Drug Act https://t.co/2pKgoTWKVw

[Regulatory Affairs Professionals Society @RAPSorg]

.@USGAO Says Adverse Event Reporting Limitations Delayed @US_FDA Action on Power Morcellators | #Regulatory Focus https://t.co/p4UIbPA1kw

[Kellie Combs @kellie_combs]

.@OPDPresources Many grappling with how to implement CWL guidance. Flexibility is good, but it raises as many questions as it answers. 2/2

[Kellie Combs @kellie_combs]

.@OPDPresources Thanks! Some clients updating policies and practices re payers bc that guidance is clearer & closer to current practices.1/2

[Kellie Combs @kellie_combs]

ICYMI, here's our alert and podcast on #FDA 1st Am memo and guidance docs re mfr communications https://t.co/mcIe1EgbiP