World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. We need a 21st-century approach that puts patient safety first.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

Pharmaceutical Technology

JUNE 14, 2023

The agreement covers rights for the development, manufacture and commercialisation of NOV03 in the country. NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface. “On

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical Safety Prescription 52

World of DTC Marketing

APRIL 15, 2021

In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The major concerns for hesitancy included worries over side effects and that the vaccine is too new.

Food and Drug Administration 203

Food and Drug Administration Government Safety Side effects 203

European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

European Pharmaceutical Review

NOVEMBER 15, 2022

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.

Manufacturing 82

Manufacturing Pharma Food and Drug Administration Safety 82

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

FDA 104

FDA Food and Drug Administration Safety Medicine 104

Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). ” CHG leverages Cresilon’s in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52