FDA Law Blog

APRIL 30, 2021

Suitability Petitions permit the submission of an ANDA that differs from an NDA-approved listed drug in strength, dosage form, route of administration, or active ingredient (in a combination drug). But until FDA approves a Suitability Petition, an ANDA cannot be submitted to the Agency for the proposed change.

Generic Drugs 40

Generic Drugs Drugs Branding Production 40

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

Drugs 61

Drugs FDA Approval Manufacturing Pharmacy 61

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. Those pharmacies aren’t rogue. That is a problem.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

FDA Law Blog

FEBRUARY 12, 2023

Despite the apparent green light, it will be a while before we see Canadian drugs on our pharmacy shelves. manufacturers to authorize the use of their FDA-approved labeling to importers and either test the imported products or give information to importers to test the products so the importers can submit pre-import requests to the FDA.

Pharmacy 97

Pharmacy Drugs FDA Approval Cosmetics 97

Pharmacy Checkers

AUGUST 2, 2019

The reality is that Americans have already been importing medications from foreign pharmacies because of substantially lower prices for many years, and the law is currently flexible to allow them to do so. The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

FDA Law Blog

JULY 12, 2021

The Order calls on FDA “to reduce the cost of covered products to the American consumer without imposing additional risk to public health and safety, [by working] with States and Indian Tribes that propose to develop section 804 Importation Programs.” See our blog post on the rule.)

Drugs 52

Drugs Cosmetics Marketing Regulation 52

Pharmacy Checkers

JANUARY 30, 2020

The Trump administration’s current drug importation plan seeks to operationalize Section 804 of the Food, Drug and Cosmetic Act to permit states to run wholesale drug importation programs – importing from Canada only, called Pathway I. And only if the drug is proven to be the exact same FDA-approved drug.

Drugs 54

Drugs Generic Drugs Cosmetics FDA Approval 54

Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts. Part J is written in three sections.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

Pharmacy Checkers

DECEMBER 20, 2019

The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices. And can’t they already import FDA-approved drugs? That probably sounds confusing.

Drugs 73

Drugs FDA Approval Cosmetics Pharmacy 73