2015 Communication Packaging 
Pharmaceutical Technology
JULY 11, 2025
Due to confidentiality around pending applications, sponsors could misrepresent significant details from FDA feedback when communicating with investors and other interested parties. How will RFK Jr’s American dream for vaccines play out? GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate?
Pharmaceutical Technology
JUNE 18, 2025
The PRV programme for rare paediatric diseases, signed into law in 2012, expired in late 2024 after it failed to make it into a US Congress funding package. In 2015, AbbVie spent $350m for a voucher to United Therapeutics, a market high, but voucher prices have gone down as more have become available for sale.
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PharmaTech
JULY 11, 2025
A 2015 cross-sectional study published in BMJ found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Moreover, when the FDA recommended a new clinical trial, that fact was left out of sponsor communications in approximately 40% of cases. References FDA.
Pharmaceutical Technology
JUNE 18, 2025
The record for the most expensive PRV occurred in 2015 when AbbVie bought a voucher from United Therapeutics for $350m. By GlobalData Learn more about Strategic Intelligence Sale figures increasing after dip PRVs were introduced in 2012 to incentivise development into non-lucrative disease areas.
FDA Law Blog: Biosimilars
JULY 10, 2025
However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. Greater transparency into our decisions will help align expectations and foster better communication among stakeholders.”
pharmaphorum
NOVEMBER 29, 2021
From clear communication with an unsettled, dispersed workforce to maintaining positive energy and managing people’s working hours, the need for open, inclusive and empathetic leadership has never been more important. . iii] It’s no longer just about the company, compensation package and secondary benefits (e.g., gym membership).
FDA Law Blog: Biosimilars
MARCH 8, 2023
Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format. For any major changes, additional time will be granted between the release of the implementation package and production deployment.
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