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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. The FDA’s Role in Protecting Our Drug Supply. Far from it.

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The Chemotherapy Drug Shortage: An Unprecedented Crisis

XTalks

The crisis is particularly concerning given that cisplatin and similar platinum-based drugs are prescribed for an estimated ten to 20 percent of all cancer patients, according to the National Cancer Institute (NCI)​​. These drugs are often generics and hence have a low unit price, making them less appealing to manufacturers.

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

Pharmacy Checkers

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe?

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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better. I have reported this to the FDA and will be seeing my doctor this week. So, what the heck happened with generic Budeprion XL? pharmacies is manufactured and sold in Canada as well.

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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Pharma companies in Baddi

Creogenic Pharma

Baddi attracted a lot of manufacturing industries and the biggest one turned out to be pharmaceutical industry. India is a major player in the global pharmaceutical industry, accounting for almost 20% of the export volume of generic drugs worldwide. Are You a Retailer ? Distributor ? Wholesaler ? Get Started with India's No.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.