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The debate on DTC marketing is going to heat up again

World of DTC Marketing

SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. DTC ads raise awareness around health conditions.

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FDA head Califf on tighter accelerated approvals and lower drug prices at JP Morgan

Pharmaceutical Technology

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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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.” Takeaways from ISPE’s GAMP 5 Second Edition update.

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Everything You Need to Know About Market Access in China

PM360

Furthermore, the Chinese government maintains its support for local manufacturers to bridge the gap left by innovative foreign drugs or to substitute them with more cost-effective local alternatives. Basic Medical Insurance (BMI), the public insurance that is organized and funded by the government, covers nearly all Chinese citizens.

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Clinical trials and pregnancy: regulators weigh in

Clarivate

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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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. The Future of Patient Influencers.

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Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

Pharmaceutical Technology

After a US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) Advisory Committee (AdCom) meeting in March 2023 voted unanimously in support of GSK’s respiratory syncytial virus vaccine, the odds for an approval have increased. This interview has been edited for length and clarity.