In-Vitro Packaging Regulation 
FDA Law Blog
NOVEMBER 16, 2021
Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.
XTalks
JANUARY 29, 2024
Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast is focused on improving its products and packaging vis-à-vis reducing emissions.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
JUNE 26, 2024
Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional).
pharmaphorum
OCTOBER 27, 2022
Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.
Advarra
SEPTEMBER 23, 2022
Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . When Does an IND go into Effect? .
The Pharma Data
JANUARY 31, 2021
Ion channels are a class of integral membrane proteins that regulate the flow of ions across the cell membrane as a means of conducting signals between cells and their environment. . TOKYO and CAMBRIDGE, England , Feb. ” About Sosei Heptares.
Pfizer
AUGUST 15, 2022
Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.
Expert insights. Personalized for you.
40 
Let's personalize your content