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Chemotherapy and Compounding – What You NEED to Know

epicur

Epicur Pharma’s Advisory Council member Ann Donoghue, DVM, MS shares her personal perspective on the important relationship between veterinary oncology and compounded medications used in chemotherapy treatments. Many of the presentations discussed the chemotherapies available to treat dogs.

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Novartis’ Pluvicto presents survival benefit for castration-resistant prostate cancer

pharmaphorum

A vast majority of patients diagnosed with CRPC already present with metastases at the time of diagnosis. The findings will be presented at an upcoming medical meeting and submitted to the FDA for regulatory approval in 2023. Prostate cancer is the most frequently diagnosed cancer in men in 112 countries.

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EU antibiotic shortages being monitored by MSSG

European Pharmaceutical Review

In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding. MSSG and the SPOC working party will continue to closely monitor the situation together with the EC and EU States.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. Violations this year so far were 9 and included risk presentation deficits (3 letters) Superiority Claims and Unsubstantiated Claims (2 each) and Promotion of an Unapproved Drug (1).

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Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Pharmaceutical Technology

The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.

Labelling 122
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5 Instances Of Challenging Antibiotic Workflows

ID Stewardship

Read all about this in the product label here. More information on ganciclovir in the label here. Compounding sulbactam-durlobactam Admittedly I have never compounded this one myself, but it just sounds like an error waiting to happen as well as a considerable time commitment. Well, maybe not. Have another one?

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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog: Biosimilars

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. 353b(a)(8). 353b(a)(8).