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Should we be worried about pharma’s supply chain?

World of DTC Marketing

We can’t continue to develop drugs the same way as we have done before. A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. Can patients really be confident in pharma supply chains?

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Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. Other medical professionals, however, are subject to the same scare tactics as consumers, ones perpetrated by drug company-funded organizations.

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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. Hopefully, the final versions of the review, which will be published in the coming weeks, will contain additional analysis and data.”

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” counterpart, the Drug Supply Chain Security Act (DSCSA) doesn’t come into full force until 2023. I agree with this 100%.

Drugs 71
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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 billion in 2022.

Sales 98
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FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public. The discussion below applies to brand-name (not generic) drugs. Drug companies make their products in many countries and ship those same drugs around the world to different markets.

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Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts.