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The internet enables misinformation on COVID

World of DTC Marketing

Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. And while there’s concern that the Covid-19 vaccines were rushed and that that means they haven’t been properly vetted or that their safety is otherwise in question, it’s simply not the case.

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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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Clinical trials and pregnancy: regulators weigh in

Clarivate

Drug developers often face a Catch-22 regarding clinical trials and pregnancy. 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? Panelists were asked to discuss the potential use of the drug during pregnancy.

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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.

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Pharma panics over patent wavers

World of DTC Marketing

The Biden administration’s decision to support a temporary waiver of Covid-19 vaccine patents prompted instant outrage in the pharma sector, which argues that the move rides roughshod over their intellectual property rights and will discourage US innovation while sending jobs abroad. This is the right and moral decision.

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