European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. The worldwide trend of using botanical drugs and strategies for developing global drugs.

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Drug Development Biosimilars Documentation Compounding 103

FDA Law Blog: Biosimilars

MARCH 13, 2024

10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,968,453 (November 29, 2023) Pursuant to 37 C.F.R. 10,544,220 (the ‘220 patent). Appendix D.

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Documentation Drug Development 59

Quality Matters

JUNE 6, 2023

Despite being called “inactive” ingredients, excipients in medicines play a vital role in drug development, delivery, effectiveness, and stability. Comprising up to 90% of individual drug products, excipients function as binders, disintegrants, solubilizers, coatings, preservatives, colors, and flavorings.

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Dosage Packaging Documentation Drug Development 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Packaging Documentation Labelling Communication 59

PharmaShots

JUNE 14, 2023

In May 2023, Varex launched its XRD 3131N digital X-ray detector to address the need for faster and more comprehensive inspection in high-paced EV battery manufacturing Diagnostic Revenue: $720.4M The company divides its business into multiple segments, including imaging solutions, healthcare & material solutions, and document solutions.

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Hospitals Documentation Drug Development 56

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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Documentation Labelling Drug Development 59

Putting Patients First Blog

MARCH 29, 2023

NHC Comments on Help Committee Pandemic Preparedness RFI (PDF) March 29, 2023 The Honorable Bernard Sanders Chair United State Senate Committee on Health, Education, Labor, and Pensions Washington, DC 20510 The Honorable Bill Cassidy, M.D. Addressing Anti-Microbial Resistance (AMR) In 2019, an estimated 1.27

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Insurance Coverage and Processing Vaccines Documentation Hospitals 40

Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. link] 6 National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Ensuring Patient Access to Affordable Drug Therapies. Nature Communications, 11(6265). and Kumar, P.

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Communication Documentation Drug Development 40

Pharmaceutical Technology

FEBRUARY 1, 2023

Cases of palivizumab-resistant RSV strains have been documented as early as 2010, roughly 12 years after the mAb entered the market. However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab.

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Vaccines Documentation Immunity Immunization 64

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. the Confirmatory Evidence Guidance, available here ) had appeared on CDER’s Guidance Agenda for the past three years.

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Drug Development Documentation Labelling Medical Records 64

FDA Law Blog: Biosimilars

APRIL 23, 2023

Other challenges in the use of an external control include concerns over potentially important treatment imbalances between arms resulting in biases that were not documented or accounted for. Tobolowsky & David B.

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Documentation Drug Development 49

FDA Law Blog: Biosimilars

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. Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents.

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Drug Development Communication Documentation Labelling 59

Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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Drug Pricing Drug Development Documentation Communication 40

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The contents of the document are currently non-binding, but once finalised will represent the current thinking of the agency.

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Drug Development Documentation Communication 52

Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). Årdal previously wrote about the voucher scheme in a February 2023 article published in The Lancet.

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Drug Development Documentation Communication 52

Pharmaceutical Technology

APRIL 24, 2023

Artificial intelligence (AI) is set to be the most disruptive emerging technology in drug development in 2023, unlocking advanced analytics, enabling automation, and increasing speed across the clinical trial value chain. Optical character recognition (OCR) can address structured and unstructured native documents.

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Documentation Medical Records Communication Drug Development 52

Pharmaceutical Technology

APRIL 27, 2023

When combined with rapid advancement in delivery technologies, mRNA has the potential to lead to breakthroughs in the development of tailored treatment approaches in a wide range of indications from cancer to rare genetic disorders while enabling rapid responses to emerging threats. billion by 2028.

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Vaccines Drug Development Documentation Communication 52