World of DTC Marketing

APRIL 12, 2021

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. In other words, money over safety.

Generic Drugs 187

Generic Drugs Manufacturing Production Drugs 187

Pharmacy Checkers

JANUARY 10, 2020

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 wanted to know if these prices were for the “same” drug. and arguably just as safe. Is it counterfeit?

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

Drug Discovery World

MARCH 29, 2023

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.”

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. 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.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Pharmacy Checkers

OCTOBER 11, 2019

It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public.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.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

MARCH 11, 2020

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.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41