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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. 10 The package, once adopted, is expected to introduce changes to regulatory exclusivity, market access, and competition rules for medicines, including biosimilars, across the EU. Document 9286/25.

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How to deal with a drug recall in pharmacy

SingleCare

Having a written pharmacy drug recall policy and procedure document in place for all staff members can help ensure a smooth process, especially if an FDA inspector decides to verify any recalled drugs at your pharmacy. Class III: The drug is not likely to cause harm to a patient’s health but may have defects in labeling or packaging.

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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. However, given that PFAS are ubiquitous in the environment from stain-resistant carpets and non-stick pans, to packaging and electronics, to name a few the task is not that simple.

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Pharmacy Law and Licensing Highlights 2025

The FDA Law Blog

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.

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ICH Q6B for Analytics

PharmTech

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

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Pharmacist to Clinical Strategy Leader: Brendan Doran on Building a Career in Biotech

The Nontraditional Pharmacist

And then how do you develop documents to basically get approval from the FDA to study your drug in humans? Sometimes we exclude medications from our protocol, various CYP enzymes and kind of going through a package insert to see, should we exclude this drug or not? So there’s still definitely a lot of PharmD in there.

FDA
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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs.