Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. On-site Evaluations.

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Regulation Drugs Manufacturing Production 98

Pharmacy Checkers

FEBRUARY 14, 2020

In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. Below are U.S.

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Branding FDA Approval Pharmacy Bioequivalency 62

Pharmacy Checkers

JANUARY 10, 2020

For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” That response is related to well-made generic drugs – not those discovered as inferior due to fraud or poor manufacturing , which is a serious problem. So, are these the “same” drug? requirements.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

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Manufacturing Drugs Production Packaging 147

World of DTC Marketing

AUGUST 7, 2022

Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The Andrew Witty, its CEO, had a 2021 pay package worth $18.4 Medicare drug insurance is a product of compromise after decades of debate in Congress. Prior authorization is out of control.

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Doctors Doctor Generic Drugs Drugs 263

Pharma in Brief

JANUARY 9, 2022

The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label.

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Regulation Manufacturing Medicine Drugs 52

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. The global revenue for Invega products was $4.14 Pfizer Inc.

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Sales Manufacturing FDA Approval Life Science 98

Pharmacy Checkers

DECEMBER 12, 2019

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.” Clearly, the FDA acknowledges the relative strength of the EU on drug safety. What about other countries?

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Drugs Manufacturing Medicine Compliance 71

Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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Production Manufacturing Generic Drugs Drugs 263

Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. Its indirect relation to personal drug importation is noted at the end of this post. It’s legal to import those drugs.

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FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

JUNE 21, 2019

Amazon’s support for The Affordable and Safe Prescription Drug Importation Act , introduced by Senator Bernie Sanders (I-VT)—to allow for the importation of lower-cost prescription drugs—would be the game changer that would have American patients cheering and the pharmaceutical industry crying. prescription drugs. wholesalers.

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Pharmacy Drugs Branding Medicine 61

FDA Law Blog

SEPTEMBER 13, 2021

Readers following drug pricing activity will recognize several strategies already associated with Senate Democrats (e.g., Medicare negotiation authority; encourage biosimilars and generic drug utilization). The HHS plan’s proposals are defined in general terms, without estimates of taxpayer savings or timelines.

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Drugs Manufacturing Generic Drugs Branding 98

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. ECONOMIC IMPACT: Canada.

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Vaccination Vaccine Antibody Life Science 92