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

The Pharma Data

MARCH 15, 2022

To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

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. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. J(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation. 15 and 16). 3) Drugs imported from Canada.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

Pharmacy Checkers

AUGUST 2, 2019

Before diving into Trump’s drug importation plan more fully, please take note that this plan actually allows for the importation of what the FDA has called “foreign unapproved drugs,” ones that they have said they don’t want Americans ordering online and importing for their own use. The FDA-approved version of a 40 mg pill is in capsule form.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

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