Drugs, FDA Approval, Generic Drugs and Pharmacy

Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost

Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.” generic for 3 of the drugs.

Generic Drugs

Generic Drugs FDA Approval Drugs Branding

When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

FEBRUARY 14, 2020

Joe and Teresa Graedon, founders of The People’s Pharmacy , not only have an admirable track record of telling health consumers how it is, but also listening to those in their readership. Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better. Compare Wellbutrin Prices.

Branding

Branding FDA Approval Pharmacy Bioequivalency

Valisure Supports Drug Importation

Pharmacy Checkers

SEPTEMBER 10, 2020

online pharmacy that actually tests the quality of medication it sends to patients and apparently, to my delight, they support drug importation as a policy to lower costs. When people go online or to their local Walgreens to buy prescription drugs domestically, they are largely relying on the regulatory strength of the U.S.

Drugs

Drugs FDA Approval Generic Drugs Branding

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

Insulin

Insulin Production FDA Approval Generic Drugs

Maine and Nevada Update Drug Price Transparency Laws

FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

Drugs

Drugs Manufacturing Generic Drugs FDA Approval

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

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’s doctor was skeptical of drugs bought online from other countries. Is the drug safe?

FDA Approval

FDA Approval Branding Pharmacy Manufacturing

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.

Generic Drugs

Generic Drugs Drugs Branding Production

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S.

Generic Drugs

Generic Drugs Drugs Branding Production

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). Generic Drug Cos. .

Vaccination

Vaccination Vaccine Drugs Regulation

Hitting Pause on Criticism of the FDA, Just for Today

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

Generic Drugs Manufacturing Regulation Drugs

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

Drugs

Drugs Manufacturing Medicine Compliance

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

OCTOBER 11, 2019

The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II. The title of this post may seem like a joke for those of you who follow the issue of drug importation in America, but it is real. Most prescription drugs sold in the U.S.

FDA Approval

FDA Approval Drugs Manufacturing Pharmacy

Pathbreakers: The journey of first generics

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year.

Generic Drugs

Generic Drugs Branding Drugs Production

Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. While small molecule drugs can be remade into identical generics, biologics are more complex. There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January.

Marketing

Marketing Pharmacy Production Branding

Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

JANUARY 6, 2023

In this most recent settlement, the drug company faced allegations of colluding with the generics company Par Pharmaceuticals to violate antitrust laws. Novartis has also been on the receiving end of litigation with the Greek health ministry, academic institutes, and more, engaging the drug company in other legal disputes.

Doctors

Doctors Doctor Drugs Sales

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Pharmacy Checkers

JANUARY 30, 2020

No, not for raising a drug price – otherwise the jails would overflow with pharma execs – but for financial fraud related to his work as hedge fund manager. Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug.

Drugs

Drugs Generic Drugs Cosmetics FDA Approval

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. counterparts.

Pharmacy

Pharmacy Drugs FDA Approval Licensing

Clinical Research Informer

Faster FDA Approvals Don’t Affect Generic Drug Availability or Cost

When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Trending Sources

Valisure Supports Drug Importation

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

Maine and Nevada Update Drug Price Transparency Laws

Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

Hitting Pause on Criticism of the FDA, Just for Today

Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pathbreakers: The journey of first generics

Humira biosimilars set the stage for long-awaited 2023 US launches

Exforge antitrust settlement caps Novartis’ year of legal disputes

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

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