Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

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Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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European Pharmaceutical Review

FEBRUARY 23, 2023

7 Raman imaging in pharmaceutical research – an overview The application of Raman spectroscopy in the medical field led to its use in pathogen screening; in turn, this has led to a role in drug development, such as time‑lapse experiments to better understand the bacterial growth‑dependent phenomena and metabolic response to novel antimicrobials.

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Labelling Packaging Drug Development 121

European Pharmaceutical Review

SEPTEMBER 2, 2022

US Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; June 2020. Available from: [link]. Available from: [link].

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Pulses

AUGUST 31, 2023

Table 2: Applications of Virtual Technology in Pharmacy Education AR VR MR XR Metaverse Virtual Laboratories √ √ 3D Anatomy and Physiology Visualization √ √ √ √ √ Drug Information and Interaction Visualizations √ √ √ Medication Administration Training √ √ √ Pharmacy Workflow and Practice Simulations √ Disease Simulation √ Medication Labeling and Packaging (..)

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European Pharmaceutical Review

FEBRUARY 14, 2024

Clinical success will then obviously drive future investment in process optimisation throughout the drug substance and drug product processes to engineer a reduction in variation through enhanced process characterisation. He is an inventor of six patents and serves as a Visiting Lecturer at Manchester University on Product Development.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

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Packaging Documentation Labelling Communication 59

Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

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Communication Drug Development Packaging Labelling 40