The FDA Law Blog

JUNE 7, 2023

The “façade of ‘negotiations’ and ‘agreements’” require Merck to communicate that it has “agreed” to an HHS-mandated price, and to endorse the viewpoint that the price is ‘fair’”, when in fact there has been neither a real agreement nor a fair price.

Communication 45

Communication 45

Hospital Pharmacy Europe

FEBRUARY 17, 2025

While pharmacist prescribing is still not present in many European countries, the UK has been benefiting from prescribing pharmacists since 2003. Despite their geographical proximity, Ireland and the UK are at very different stages of implementing pharmacist prescribing, highlighting the varying levels of its adoption across Europe.

Hospitals 59

Hospitals Patient Care Clinic Management Communication 59

The Checkup by Singlecare

DECEMBER 6, 2023

Be mindful of the risk of additive side effects and direct drug interactions, which may occur when metronidazole is used in combination with prescription and over-the-counter medications or supplements.

Dosage 52

Dosage Labelling Communication Hospitals 52

ISPE

MAY 10, 2023

5 (2003): 395–413. You may unsubscribe from these ISPE communications at any time. Presented at the 2017 IFIP/IEEE Symposium on Integrated Network and Service Management (IM), Lisbon, Portugal, 8–12 May 2017: 772–77. doi:10.23919/INM.2017.7987376 2017.7987376 12 Jansen-Vullers, M. van Dorp, and J. Microsoft.com.

Chemotherapy 52

Chemotherapy Documentation Dosage Labelling 52

ISPE

NOVEMBER 2, 2022

As a result, I was asked to present learning points and outcomes of that inspection at a GAMP Forum in San Francisco in January 2003. Those began 20 years ago when he was involved in a major FDA inspection by Robert Tollefsen and Thomas Arista that significantly changed computer system validation in the industry. “As

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

MARCH 7, 2023

Published 6 February 2003. Published 6 February 2003. The PACMP requires approval by the regulatory authority, and the conditions and acceptance criteria outlined in the protocol must be met and results communicated to the regulatory authority in the manner previously agreed, in order to implement the change(s).

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

SEPTEMBER 11, 2023

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. You may unsubscribe from these ISPE communications at any time. McGarvey, and T.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

MAY 9, 2023

Published February 2003. Published February 2003. You may unsubscribe from these ISPE communications at any time. “ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug Substances and Products.” link] 13 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 10, 2023

Journal of Machine Learning Research 3 (2003): 1137–55. “An Important Next Step on Our AI Journey.” The Keyword. Published 6 February 2023. link] 3 Bengio, Y., Ducharme, and P. A Neural Probabilistic Language Model.” link] 4 Brown, T., Subbiah, J. Dhariwal, et al. Language Models Are Few-Shot Learners.”

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 26, 2022

Published 2003. You may unsubscribe from these ISPE communications at any time. “EudraLex, Volume 4: EU Guidance for Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use. Part I: Basic Requirements for Medicinal Products.” link] basic-requirements-for-medicinal-products. European Commission.

Vaccines 97

Vaccines Compounding Documentation FDA 97

European Pharmaceutical Review

SEPTEMBER 22, 2023

Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. Andrea Pfeifer, PhD In 2003, Andrea Pfeifer co-founded AC Immune SA. Brain Communications.2022;4(1). He then worked as a clinical scientist for a med tech company developing spinal cord stimulation for people living with spinal cord injury.

Immunization 97

Immunization Vaccines Communication Labelling 97

pharmaphorum

FEBRUARY 26, 2021

The company has also faced claims that it did not adequately communicate the risks of its opioid painkillers in its marketing, contributing to the US’ ‘opioid epidemic’, and that its talc products could contain small amounts of asbestos and lead to cancer. Litigation & controversy. CEO Alex Gorsky, who was appointed in 2012.

Vaccines 126

Vaccines Labelling Communication 126

pharmaphorum

DECEMBER 22, 2022

There were screening recommendations back in 2003 and they have yet to be fully implemented. Korenjak philosophically entered the conversation with the comparison of the water jug on the table before him: he was thirsty, but he couldn’t reach the water, and a similar experience is what is happening in Europe, he said.

Vaccines 98

Vaccines Communication 98

The Checkup by Singlecare

NOVEMBER 13, 2023

Asthma About 27 million people in the United States have asthma , which is equivalent to 1 in 12 people, according to the Asthma and Allergy Foundation of America. Asthma is a non-communicable disease that causes difficulty in breathing, and it may cause sharp pain on the right side of the chest.

Mayo Clinic 52

Mayo Clinic Vaccines Chemotherapy Communication 52