Remove 2018 Remove Documentation Remove Dosage
article thumbnail

Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Insiders

Sign Up for our Newsletter

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

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

article thumbnail

How much is Basaglar Kwikpen without insurance?

The Checkup by Singlecare

Studies from 2018 and 2022 have shown similar efficacy and safety in treating patients with Type 2 diabetes. How long this pen lasts will depend on your dosage. Each pen contains 300 units, and the maximum starting dosage is 10 units per day. Lantus has two FDA-approved biosimilars : Semglee and Rezvoglar.

article thumbnail

ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done.

article thumbnail

SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 10 April 2018. Published 5 April 2018. Lakerveld, B. Benyahia, P. Barton, R.

article thumbnail

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

The FDA Law Blog

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).