The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. 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.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. e), the Agency will approve or deny the petition no later than 90 days after the petition is submitted.”

Generic Drugs 40

Generic Drugs Drugs Branding Production 40

FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. e), the Agency will approve or deny the petition no later than 90 days after the petition is submitted.”

Generic Drugs 40

Generic Drugs Drugs Branding Production 40

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . The medications that we obtain in the U.S., and other high-income countries.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

Pharmacy Checkers

JANUARY 30, 2020

Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug. Basically, the charge is that the Vyera took myriad actions to prevent a lower-cost generic drug from coming to market.

Drugs 54

Drugs Generic Drugs Cosmetics FDA Approval 54

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. Part J is written in three sections.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41