Remove en accessibility-statement
article thumbnail

Industry group says FDA botched COVID-19 convalescent plasma guidance

pharmaphorum

Convalescent plasma treatment involves giving COVID-19 patients antibody-rich blood plasma from people who have already recovered from the disease, and has already been used in 70,000 people in the US under an Expanded Access Programme launched in April.

Antibody 105
article thumbnail

Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

Teva submitted an ANDA in 2002, and after some complicated regulatory history, ultimately carved-out the congestive heart failure indication by way of a section viii statement. Teva moved for a rehearing en banc with the support of the generic industry. Teva decision , the skinny label may be dead.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

AbbVie Submits Regulatory Applications for SKYRIZI® (risankizumab) in Psoriatic Arthritis to FDA and EMA

The Pharma Data

Forward-Looking Statements. Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Rhumatisme psoriasique en France , du nourrisson à la personne âgée?: Accessed on April 1, 2021. Galezowski, A.,

article thumbnail

Keeping tabs on Covid-19: Sanofi and Luminostics develop self-testing smartphone…

The Pharma Data

We will need to ensure there’s adequate supply from the start of the campaign, and adequate resource for practices to deliver a vaccine program en masse. An anonymous respondent of the survey commented: “Patient education and myth busting in media is vital.

article thumbnail

The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

Yet… Petitioners filed PMTAs for their flavored nicotine liquids, which included marketing and sales access restriction plans, with FDA before the deadline. In August 2021, FDA issued a press release announcing the denial of 55,000 flavored e-cigarette applications en masse.

article thumbnail

COVID-19 Pandemic Coverage

XTalks

Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. FDA commissioner Stephen Hahn himself made a statement echoing Trump that 35 more people out of 100 would survive the coronavirus if treated with the plasma.

article thumbnail

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

Upon purchase, you will be redirected to a customers’ only area offering access to all content of the “Let’s Quit Sugar” system. ClickBank’s role as retailer does not constitute an endorsement, approval or review of these products or any claim, statement or opinion used in promotion of these products. Pothos EN, Hernandez L, Hoebel BG.

Insulin 52