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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. The fourth version was introduced in 2018. percent to as low as 0.20

Packaging 111
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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. About the author. Camptosar prescribing information.

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Rx

RX Note

Introduction In August 2018, I started a self-initiative drug database project, named "Rx". Uses and off-label use (with recommended dosage) Oral medication administration Advice to patients and Essential points, such as adverse drug reaction and role in therapy. Storage requirement: Cold-chain item?

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Glaucoma

RX Note

If response to a prostaglandin analogue is poor, switching to another one may be effective as drugs in this class are structurally different.

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Pain

RX Note

Visual analogue scale : 10-cm-long lines labelled with an extreme at each end, usually "no pain at all" and "worst pain imaginable". Strong opioids, of which morphine is considered the gold standard, have no ceiling effect, and therefore increased dosage continues to give increased analgesia, but side effects often limit the effectiveness.

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Herbs and Supplements

RX Note

A quick question: Do you know the common dosage of St. FDA requires the labels of all herbal supplements to include the complete list of ingredients and manufacturers must follow good manufacturing practices (GMP) to ensure that supplements are processed consistently and meet quality standards. John's Wort or its typical uses?