Pharmaceutical Technology

JANUARY 6, 2023

In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Please check your email to download the Report.

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Documentation FDA Hospitals Dosage 97

Hospital Pharmacy Europe

FEBRUARY 22, 2024

Their training and skills enable them to interpret and communicate complex medicines-related information to patients and other health professionals. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: An open-label, multicentre, controlled, cluster-randomised crossover implementation study. 2024 NHS England.

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Hospitals Patient Care Medical Records Dosage 111

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. GlobalData predicts that Comirnaty’s sales will increase by more than 20% between 2024 and 2027. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Vaccines Immunization Medical Schools FDA 59

PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments.

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FDA Compounding Hospitals Vaccines 40

The FDA Law Blog

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Would any such failure to meet DAP goals be reflected in labeling?

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FDA Communication Documentation Labelling 59

IDStewardship

DECEMBER 11, 2024

In this articlea selection of notable peer-reviewed publications from 2024 are provided. BCPS, BCIDP 2024 has been an interesting year forinfectious disease literature dissemination. Article Selection by: Bassam Ghanem, Pharm.D., MS, BCPS ArticleConstruction by: Timothy P. Gauthier, Pharm.D., Mastodon sure did not.

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HIV Treatment and Prevention Agents Labelling Hospitals FDA 363

European Pharmaceutical Review

JANUARY 20, 2025

Real-time label updates are also made possible by ePI, which means patients can always access the most up-to-date information on their medication, potentially enhancing patient safety. Moreover, fostering a culture of transparency and open communication will help build trust and encourage widespread adoption. Cited 2024Aug].

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Communication Packaging Labelling Hospitals 52

The FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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