Cosmetics In-Vitro Marketing Production 
Roots Analysis
AUGUST 7, 2023
Moreover, cell based biomanufacturing imposes inherent limitations on the effective production of biologics. Moreover, cell based biomanufacturing imposes inherent limitations on the effective production of biologics. Cell free expression is carried out using cell free system or commercially available cell free expression kits.
FDA Law Blog
NOVEMBER 16, 2021
Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. In the pre-market area, Ms. In the post-market area, Ms. Prior to joining the Firm, Ms. In addition, Ms.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
pharmaphorum
OCTOBER 27, 2022
The Guidance applies to both product-related and therapeutic-area-related activities. Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. What is the scope of the Guidance?
FDA Law Blog
JULY 8, 2021
Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). If enacted, the VALID Act would completely reshape the regulation of all diagnostic products in the United States.
FDA Law Blog
APRIL 19, 2021
FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.
FDA Law Blog
OCTOBER 6, 2023
The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.
Pfizer
DECEMBER 13, 2022
Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.
Expert insights. Personalized for you.
52 
Let's personalize your content