FDA Law Blog

APRIL 30, 2021

According to the press release on the bill: The Simplifying the Generic Drug Application Process Act repeals section 505(j)(2)(C) of the Food Drug and Cosmetic Act (FDCA) so that sponsors can submit generic drug applications (ANDAs) without the need for the U.S. Food and Drug Administration (FDA) to first grant a suitability petition.

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XTalks

FEBRUARY 8, 2021

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. As a subset of biosimilars, interchangeable biological products can be substituted for the reference product at the pharmacy level, without the input of the prescribing physician.

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The Pharma Data

MAY 27, 2022

It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”. On Tuesday, the FDA announced that it informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand.

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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(3) is specific to Canada and basically tells the FDA to permit personal importation from licensed pharmacies that require a valid prescription. 15 and 16).

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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.

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Pharmacy Checkers

JANUARY 30, 2020

Here’s what Azar had to say in an HHS press release from 2018: “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. That would not include GlaxoSmithKline’s really cheap Daraprim from the EU.

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Pharmacy Checkers

DECEMBER 20, 2019

The proposed rule provides specifics so that states contemplating or already formulating wholesale drug importation programs have a shot at gaining approval for those programs, per Section 804 of the Food, Drug and Cosmetic Act. Then pharmacy benefit managers (PBMs) negotiate a lower price with the drug company. Here’s Politico.

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Pharmacy Checkers

AUGUST 2, 2019

These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. This recognition of equivalent brand drug safety is a step in the right direction. The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act.

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