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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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PEM POCUS Series: Pediatric Renal and Bladder Ultrasound

ALiEM - Pharm Pearls

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Cysts will have a more spherical shape and will not “communicate” with one another [5]. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4).

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Root Causes of Depression and Hashimoto’s

The Thyroid Pharmacist

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. Published 2004 Aug 18.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog: Biosimilars

It will be important for FDA to communicate to sponsors its views on whether a product would address an unmet medical need on mechanistic grounds to help ensure greater certainty for investment in the development of therapies for these serious conditions. in Duchenne Muscular Dystrophy).