Remove FDA Remove Government Remove Prescription Remove Specialization
article thumbnail

GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” FDA, 2022. . About the authors.

article thumbnail

How to Work with Patient Advocates, Influencers, and Ambassadors

PM360

When asked how pharma companies could earn more trust from patients, lower drug prices and other financially supported access to treatment ranked as the top things patients would want to see along with more educational resources and support of government policies to protect patients’ rights.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Selling Effectively In Medical Sales With John Crowder

Evolve Your Success

— Watch the episode here Listen to the podcast here Selling Effectively In Medical Sales With John Crowder We have with us another special guest. A lot of organizations that may have a sales model don’t probably follow the prescription that we deliver or the method that we deliver to them, which is why they contract us.

article thumbnail

Industry Briefs November 2022

PM360

The two retail pharmacy giants have announced their intention to settle lawsuits regarding inappropriate opioid prescriptions at $5 billion each. billion to local governments and about $130 million to Native American tribes over a decade. billion to governments and $155 million to tribes over 15 years. Local and U.S.

article thumbnail

FDA AdCom votes unanimously in favour of OTC oral contraceptive

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA has no obligations to follow the recommendation of AdComs, though the vote will likely be weighed in the agency’s final decision.

FDA 52
article thumbnail

Uri Goren

Cadensee

48:12 What is Uri Gorenseeing that is special in the Israeli Digital Health ecosystem? So, you see on one side, there's a special body of the FDA trying to listen to patients to find new targets for health and for pharmaceutical technology. I think vaccines, in most cases, is a special case. It's a different part of it.