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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date. on placebo.

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

The FDA Law Blog

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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The key role of GMP analytical testing for drug products

European Pharmaceutical Review

One of the most significant challenges is keeping up with the changing regulatory requirements set by agencies such as the US FDA, EMA and International Council for Harmonisation (ICH). For solid dosage forms, including capsules, tablets, or film-coated tablets, dissolution tests are conducted. Any identified gaps have been addressed.

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Cymbalta generic availability, cost, and dosage

The Checkup by Singlecare

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. Cymbalta may have several off-label uses in addition to its FDA-approved uses. The post Cymbalta generic availability, cost, and dosage appeared first on The Checkup.

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Prednisone anxiety: Why it happens and how to cope

The Checkup by Singlecare

Prednisone is an FDA-approved prescription medication to treat a range of common conditions characterized by inflammation caused by the immune system. Natural remedies for anxiety Dr. Kim recommends communicating your side effects closely with your healthcare provider. In such cases, a dose adjustment might be appropriate.

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Is famotidine safe during pregnancy?

The Checkup by Singlecare

Food and Drug Administration (FDA). Even though famotidine has not been tested in humans, experience and many retrospective studies have shown when used appropriately and in recommended dosages, it is safe in pregnancy,” says Los Angeles-based OB-GYN and urogynecologist Michael Tahery, MD. Can you take famotidine while pregnant?

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