FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. In Section I.A,

Drugs 59

Drugs Manufacturing Generic Drugs Production 59

Drug Channels

FEBRUARY 23, 2021

In this issue: Payers confess: Patients lose from copay accumulators Humana joins the Express Scripts GPO Hospitals vs. PBMs over specialty pharmacy white bagging Let’s all follow the Buy-and-Bill Dollar! Plus, entrepreneurial pharmacy owner Dave Marley demonstrates the power of innovation. Marley Drug generated $1.7

Pharmacy 52

Pharmacy Drugs Production Generic Drugs 52

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. In fact, many people reported that when they were switched to the Teva generic Wellbutrin XL, their depression returned. Compare Wellbutrin Prices.

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

Drug Discovery World

APRIL 10, 2023

Could India become an important centre of drug discovery innovation? India is traditionally known as ‘the pharmacy of the world’ due to its huge pharmaceuticals manufacturing capacity and high quantity of exports, particularly generic medicines and vaccines.

Genome 52

Genome Genomics Drugs Life Science 52

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. pharmacies. John wanted to know if these prices were for the “same” drug. and arguably just as safe.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

Drugs 45

Drugs Manufacturing Generic Drugs Production 45

Pharmacy Checkers

DECEMBER 5, 2019

While the DAL doesn’t legalize personal medicine imports of drugs approved in a foreign market, China will exempt or be lenient for imports of small quantities of such drugs. It will be interesting to see how this change in law impacts the international online pharmacy market.

Sales 64

Sales Medicine Pharmacy Drugs 64

Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage.

Drugs 298

Drugs Manufacturing Production Pharmacy 298

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

Production 78

Production Insulin Branding Generic Drugs 78

pharmaphorum

SEPTEMBER 9, 2022

The pharmaceutical industry is globalized: generic drugs manufactured at sites in India will be produced using imported materials and be shipped to distributors worldwide, who will coordinate distributing them to retail businesses or pharmacies,” said the whitepaper.

Production 98

Production Pharma Companies Generic Drugs Contamination 98

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

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

JANUARY 16, 2020

The company Blink Health is advertising Canadian drugs on Google, even though it does not sell medication from Canadian pharmacies. This distinguishes them other drug price comparison leaders that offer pharmacy discount cards and coupons for U.S. pharmacies – ours is called the PharmacyChecker Discount Card.

Pharmacy 74

Pharmacy Drugs Branding Generic Drugs 74

Drug Discovery World

AUGUST 8, 2023

In the global pharmaceuticals market, India ranks third worldwide for production by volume and the domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 1. To many, the country is referred to as the ‘pharmacy of the world’. So, what is driving this success, and will it continue?

Research 52

Research Drugs Genome Genomics 52

Druggist

MARCH 25, 2021

Can I ask the pharmacy to dispense Cerazette instead of Cerelle? Do generic, and branded drugs produce exactly the same effect? . In terms of prescribing, both contraceptives are regarded as the same drug. . Can I ask the pharmacy to dispense Cerazette instead of Cerelle? . How can I get Cerazette pill?

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

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. They both require the most advanced cGMP or current Good Manufacturing Practices.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. Its indirect relation to personal drug importation is noted at the end of this post. Some of this is guesswork.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

APRIL 8, 2020

The pharma-funded and industry opponents of drug importation from Canada just love to talk about how “ even the Canadian government opposes importation.” For a quick clarification, Canada has not minded or stopped its pharmacies from safely dispensing medicines by mail to Americans. That’s personal drug importation. I’m all in.

Generic Drugs 64

Generic Drugs Drugs Pharmacy Medicine 64

Pharmacy Checkers

MAY 1, 2020

In late March, drug giant Bayer Pharmaceuticals, out of the goodness of its heart, agreed to donate three million tablets of chloroquine phosphate to help the Trump administration get this drug into U.S. pharmacies. If you don’t, then you’re much more likely to get a counterfeit or otherwise substandard drug.

Drugs 53

Drugs Pharmacy Manufacturing Production 53

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. However, that percentage of multiple first generics is not very high—approximately 10.6%

Generic Drugs 246

Generic Drugs Branding Drugs Production 246

Pharmacy Checkers

JUNE 21, 2019

With drug prices in the spotlight of our national healthcare debate, one could certainly view Amazon’s entry last year into the pharmacy space as a welcome development. to bring lower-cost generic drugs to market faster are a great step in. prescription drugs. The price at a pharmacy.

Pharmacy 61

Pharmacy Drugs Branding Medicine 61

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

Marketing 262

Marketing Pharmacy Production Branding 262

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Novartis $245 million settlement.

Doctors 242

Doctors Doctor Drugs Sales 242

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

FDA Law Blog

SEPTEMBER 13, 2021

A final rule to establish a Most Favored Nation model to base Medicare drug payment on international prices was enjoined by two federal courts, and HHS recently proposed to rescind the rule (see our post here ). The pieces of major drug pricing and payment reform are falling together. Court of Appeals (again, see our post ).

Drugs 98

Drugs Manufacturing Generic Drugs Branding 98

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Here again, the stock markets are functioning in a parallel universe. Drugs and Vaccines. billion in June.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92