Regulatory professional and engineer developing #CombinationProducts. (Tweets are mine alone and do not necessarily reflect the views of my employer.)
New Jersey
Joined May 2011
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Ethicon, Inc. Biosurgery is recruiting for an Associate Director and a Manager for Global Regulatory Affairs, CMC. If you are ready to lead a team of regulatory professionals and partner with cross-functional stakeholders to obtai…lnkd.in/gQcTfcKE lnkd.in/gTpzritZ
We're hiring! If you have regulatory experience with drug-device #combinationproducts, apply here: linkedin.com/jobs/view/25590…
We're hiring! If you have regulatory experience with drug-device combination products, apply here:
jobs.jnj.com/jobs/2105897895…
Come join our combination products regulatory team! If you have experience developing drug-device combination products and are knowledgeable about medical device and combination product regulations, apply here:
jobs.jnj.com/jobs/1333200319…
We're hiring! If you are interested in joining our team responsible for developing CMC regulatory strategies for global drug-device combination product applications, apply at jobs.jnj.com/jobs/2411191224…
FDA draft guidance on requesting feedback for #combinationproducts recently issued:
fda.gov/media/133768/downloa…
FDA issues draft guidance for industry on how to approach bridging in NDAs or BLAs for drug-device and biologic-device single entity or copackaged #combinationproducts
fda.gov/regulatory-informati…
EBE-EFPIA publishes final position paper on Article 117 of the EU MDR: Labelling Requirements for Prefilled, Non-Reusable, Integral Drug-Delivery Device #CombinationProducts
ebe-biopharma.eu/publication…
FDA Announces Availability of Draft Guidance – Transdermal and Topical Delivery Systems – Product Development and Quality Considerations
fda.gov/regulatory-informati…
Swissmedic Details Plans to Align #CombinationProduct Rules With EU
raps.org/news-and-articles/n…
FDA Announces Availability of Draft Guidance on Type V DMFs for CDER-Led #CombinationProducts Using Device Constituent Parts with Electronics or Software
fda.gov/media/132043/downloa…
New FDA Guidance issued- Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER
fda.gov/media/131911/downloa…
Regarding FDA’s integrated review proposal-
raps.org/news-and-articles/n…
Concerns for ‘conflicting’ EU clinical requirements for drug-device #combinationproducts
pink.pharmaintelligence.info…
Final FDA guidance on Postmarketing Safety Reporting for #CombinationProducts now available
fda.gov/media/111788/downloa…
#humanfactors considerations when delivering high-viscosity large molecules via pre-filled syringe, auto-injector, or on-body injector #combinationproducts
meddeviceonline.com/doc/key-…
FDA announces public health emergency prioritization of ANDAs for drug products for the emergency treatment of opioid overdose
fda.gov/media/89061/download…
FDA issues draft guidance on #combinationproduct IFU content and format: fda.gov/media/128446/downloa…
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FDA's proposed integrated review template (s3.amazonaws.com/public-insp…) would replace separate discipline-based review documents with a collaborative document containing less information, pink.pharmaintelligence.info…