Roots Analysis
AUGUST 7, 2023
On the other hand, cell free system / cell free expression system are in-vitro platforms that harness the transcription and translation machinery of living cells, in the form of cell lysates, to synthesize various types of biologics, particularly proteins. Interestingly, most of these kits are used for cell-free protein expression.
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
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? Companies can sponsor website content if the role of the company is made clear.
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). The bill creates a new category, called In Vitro Clinical Tests (IVCTs), which encompasses both distributed IVD products and laboratory tests.
FDA Law Blog
DECEMBER 6, 2023
We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States. The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. FDA seems unconcerned by this prospect.
FDA Law Blog
APRIL 19, 2021
As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval. We have blogged recently about several FDA setbacks in court ( here , for example). Add one more to that tally.
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