Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. Final Regulation Issued for “Intended Use”.

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Pharmaceutical Technology

JULY 25, 2022

The only way forward for generics producers. Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. Supply chain issues also come into play, meaning that owning proprietary API production is an advantage, he says.

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products. Continue to STAT+ to read the full story…

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Drug Patent Watch

JANUARY 13, 2025

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. Similarly, the European Medicines Agency (EMA) has been at the forefront of biosimilar regulation, with a well-established approval process in place since 2006.

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FDA Law Blog

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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Production Insulin Branding Generic Drugs 78

World of DTC Marketing

AUGUST 7, 2022

Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The 87% of doctors say patients’ conditions have worsened because of red-tape regulations, and 83% worry the patients will suffer prolonged pain. Prior authorization is out of control. The result:?

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Pharmaceutical Technology

FEBRUARY 24, 2023

The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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ACRP blog

FEBRUARY 11, 2025

If theres one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, its change. This is a sponsored message. The Academy agenda covers: Human research protections U.S.

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Compliance Clinical Research Research Regulation 59

Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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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. for the treatment of diabetes. Biosimilars marketed in the U.S.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.

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pharmaphorum

JULY 28, 2022

These supply chain issues raise significant risks for the industry due to shortcuts being taken that are not based on product safety and quality. Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Tackling shortages.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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pharmaphorum

JULY 29, 2021

In a statement, Advanz said that it “utterly disagrees” with the CMA’s decision, saying it invested significantly to keep the product on the market to the specifications required by the Medicines and Healthcare products Regulatory Agency (MHRA). ” Advanz itself was directly fined £40.9 million and £51.9

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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.”.

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Generic Drugs Manufacturing Drugs Regulation 68

Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Those 38 products generated just $10bn of the $316bn industry’s entire portfolio of medicines.

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Medicine Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

NOVEMBER 21, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.

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FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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Cosmetics Compliance Generic Drugs Regulation 59

FDA Law Blog

JUNE 28, 2023

1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

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FDA Law Blog

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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FDA Law Blog

JANUARY 22, 2024

Led by former federal prosecutor Jill Furman, OC is charged with shielding consumers “from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions.” This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities. Clinical Trials.

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Compliance Clinical Trials Clinical Trials Regulation 59

Pharmacy Checkers

SEPTEMBER 10, 2020

Food and Drug Administration to make sure those drugs will work as directed by their prescribers. While the FDA is known as a top drug regulator, for all intents and purposes, Valisure is saying that you can’t fully trust them. Because they don’t do adequate testing to prove safety and effectiveness of drugs.

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FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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FDA Law Blog

SEPTEMBER 19, 2023

The FTC expressed concern that patent listings that do not meet the statutory criteria undermine the competitive process, may disincentivize investment in developing generic and follow-on products, and reduce patient access to more affordable drugs thereby increasing costs to the healthcare system.

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Drugs Branding Drug Delivery Systems Generic Drugs 105

FDA Law Blog

AUGUST 7, 2024

On July 30, brand name drug sponsor Novartis asked the District Court for a Temporary Restraining Order ( here and here ) enjoining FDA’s approval of a generic version of its ENTRESTO (sacubitril and valsartan) with certain dosing and indication information carved-out or modified.

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FDA Approval Branding Regulation Drugs 59

FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form.

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Drugs Production Containment Generic Drugs 59

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market.

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Pharmacy Checkers

JANUARY 10, 2020

That word “same” is hard to answer when it comes to prescription drugs. For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” FDA and Alipza by the United Kingdom Medical and Health Product Regulatory Authority. FDA: PIERRE FABRE MEDICAMENT PRODUCTION.

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FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information.

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pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

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Dermatology Drugs Hormones FDA Approval 52

FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. By following these tips, industry may be able to foster a productive and constructive engagement with FDA, leading to favorable outcomes for the development of new medical products and a strengthened relationship going forward.

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Production Generic Drugs Regulation Drugs 53

FDA Law Blog

AUGUST 16, 2021

While generic drugs as we know them are a creation of the 1984 Hatch-Waxman Amendments, the Federal Register Notice explains that FDA first introduced the concept of an ANDA in 1968 to facilitate approval of Drug Efficacy Study Implementation (DESI) drugs.

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Production Drugs Generic Drugs Cosmetics 52

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. We address each below.

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

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FDA Law Blog

FEBRUARY 1, 2022

To that end, FDA announced that it would take the public input it has received and form a working group to address efforts to “modernize the Orange Book, improve transparency, and provide useful information to regulated industry and the public” by…considering the comments that it has supposed to have been considering all along.

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