Kellie Combs

290 posts

Kellie Combs

@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.

Washington, DC انضم Ekim 2013

200 يتبع210 المتابعون

Kellie Combs أُعيد تغريده

Laura Helbling@Laura_H·16 Kas

Full FDA announcement on regen medicine framework: fda.gov/NewsEvents/New… twitter.com/Laura_H/status…

Laura Helbling@Laura_H

Three regen med/HCT/Ps guidances announced in Fed Reg today. Expedited Programs for Regen Med Therapies for Serious Conditions, eval of devices used with RMATs, and Reg Considerations of HCT/P products "Minimal Manipulation and Homologous Use" #FDA twitter.com/Laura_H/status…

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Kellie Combs@kellie_combs·16 Eki

CA enacts bill on drug pricing transparency. See R&G's analysis here: ropesgray.com/newsroom/alert…

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Regulatory Affairs Professionals Society@RAPSorg·12 Eki

REMS Format and Content: @US_FDA Offers Draft Guidance | #Regulatory Focus bit.ly/2yHiyia #FDA

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Kellie Combs@kellie_combs·11 Eki

New study on DTC suggests emphasis on serious risks better than listing all risks: fiercepharma.com/marketing/oppo…

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Jeff Overley@JeffOverley·3 Eki

From a new warning letter: The FDA does not find hippie-dippie granola labeling to be charming fda.gov/ICECI/Enforcem…

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Kellie Combs@kellie_combs·7 Ağu

See R&G's summary of the #FDARA legislation here: ropesgray.com/newsroom/alert…

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Kellie Combs@kellie_combs·18 Nis

NIH updates CT.gov to provide info on protocol submission and other requirements under new rule: prsinfo.clinicaltrials.gov

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John Kamp@rxvoice·17 Nis

How will this Congress approach medical marketing issues? cohealthcom.org/2017/04/17/kam…

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Kellie Combs@kellie_combs·17 Mar

Big news this morning. #FDA delays effective date of intended use rule until March 2018 and reopens comment period: s3.amazonaws.com/public-inspect…

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Tom Burton@TomBurtonWSJ·12 Mar

President Donald Trump to nominate Scott Gottlieb to lead FDA . My @WSJ story wsj.com/articles/trump…

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Bloomberg@business·7 Mar

Trump sends pharma stocks tumbling with new tweet on drug prices bloom.bg/2n1GMuE

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Andy Biotech@AndyBiotech·23 Şub

FDA CDER 2016 Update for Rare Diseases fda.gov/downloads/Abou… Nice slide deck from Dr. Richard Moscicki

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Matthew Herper@matthewherper·21 Şub

An FDA reform agenda: What would Commissioner Scott Gottlieb do in his first six months? endpts.com/an-fda-reform-…

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John Kamp@rxvoice·15 Şub

Pharma industry shuns Trump push for radical shift at FDA reut.rs/2lfxUmY via @Reuters

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Kellie Combs@kellie_combs·15 Şub

China #FDA amends med device recall rules. See R&G analysis here: ropesgray.com/newsroom/alert…

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Zach Brennan@ZacharyBrennan·10 Şub

.@ChuckGrassley Opens Inquiry Into Orphan Drug Act raps.org/Regulatory-Foc…

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Regulatory Affairs Professionals Society@RAPSorg·9 Şub

.@USGAO Says Adverse Event Reporting Limitations Delayed @US_FDA Action on Power Morcellators | #Regulatory Focus bit.ly/2kJkOvO

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Kellie Combs@kellie_combs·8 Şub

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

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Kellie Combs@kellie_combs·8 Şub

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

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Kellie Combs@kellie_combs·8 Şub

ICYMI, here's our alert and podcast on #FDA 1st Am memo and guidance docs re mfr communications ropesgray.com/newsroom/alert…

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اكتشف

@US_FDA @WSJ @Reuters @ChuckGrassley @USGAO @OPDPresources @elonmusk @BarackObama