Communication FDA Magazine 
Pharmaceutical Technology
JUNE 6, 2023
In a 2022 annual report, the US Food and Drug Administration’s (FDA) Office of Generic Drugs stated it had approved 106 first generics— the introductory generic competitors of branded drugs. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
The FDA Law Blog
APRIL 25, 2024
Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g., l)(1) (e.g.,
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
pharmaphorum
JUNE 2, 2022
While the number of drugs approved by the FDA has increased significantly in the last 5 years , average peak sales have declined since 2010. While multichannel campaigns consist of communicating similar messages across several channels, omnichannel experiences provide the most relevant content at the right point in the stakeholder’s journey.
pharmaphorum
FEBRUARY 18, 2021
In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. 10 Since FDA approval in 1998 the ‘Little Blue Pill’ had some of the fastest prescription uptakes and sales growth of any medication, bringing in $400 million in revenue in its first quarter after launch and going on to produce annual sales of about $1.8
ISPE
OCTOBER 27, 2022
Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. You may unsubscribe from these ISPE communications at any time. A few innovators have shepherded this industry through these down years and managed to build impressive pipelines.
ISPE
AUGUST 29, 2022
In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.
ISPE
OCTOBER 26, 2022
For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.
Expert insights. Personalized for you.
52 
Let's personalize your content