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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

FDA Law Blog: Biosimilars

While much of the focus has been on how these cuts may impact application review timelines and industry engagement, see earlier post about the effect on generic drugs, another quieter consequence is emerging a significant slowdown in the availability of information that FDA is required to produce under the Freedom of Information Act (FOIA).

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Pharmacy Law and Licensing Highlights 2025

FDA Law Blog: Biosimilars

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. Hyman, Phelps & McNamara, P.Cs

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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Development and Manufacturing of Primary Packaging and Medical Devices

Pharmaceutical Technology

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Biosimilars

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.

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EMCrit 1:1 Nursing Podcast 002 – Post-Intubation Sedation (Pain, Agitation, & Delirium)

EMCrit Project

Intubated patients in the ED should have soft, wrist restraints places without the need for arduous, high-risk documentation or sitters Intubation Checklist EMCrit 176 – Updated EMCrit Rapid Sequence Intubation Checklist Awareness during Paralysis EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

Labelling 100
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Leading clinical packaging companies in contract marketing

Pharmaceutical Technology

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.