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FDA OPDP Look Back at 2021 – The Yawning Gap

Eye on FDA

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist. in November 2009.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

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Time for FDA’s OPDP to Fill the Gaps on Digital and Social Media

Eye on FDA

The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter. One of them was about the appropriate use of links.

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

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Solutions to Increase Low Libido in Those with Hashimoto’s

The Thyroid Pharmacist

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2009-0041.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

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Common Hashimoto’s Patterns Seen in the GI-MAP Test

The Thyroid Pharmacist

After being diagnosed with Hashimoto’s in 2009, I spent a lot of time, money, and resources on trying to figure out my root cause. As such, I re-analyzed the data for the “presence” of parasite DNA labels, and the incidence was substantially higher… 274 total parasites were detected!