Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage.

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Drug Patent Watch

APRIL 8, 2025

Consider the impact of new regulations, such as those related to biosimilars or generic drugs. Evaluate the number of products in development, their potential market size, and the competition. Regulatory Environment : Changes in regulatory policies can impact a company's valuation.

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Pharma Companies Generic Drugs Production Regulation 82

Drug Patent Watch

JUNE 8, 2021

When it comes to pricing generic drugs, there are a number of factors that come into play. In countries without drug price regulations, the pricing is based largely on profitability.…. The post Strategies for Pricing Generic Drugs appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,

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Regulation Drugs Manufacturing Production 98

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions.

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Generic Drugs Development Bioequivalency Drugs 52

Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.

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Regulation Medicine Generic Drugs Containment 98

STAT News

DECEMBER 13, 2022

WASHINGTON — The Biden administration signaled Monday that it will require health plans on federal exchanges to cover more of the costs of generic drugs, a small tweak that nevertheless has industry groups divided on how best to manage drug costs. Continue to STAT+ to read the full story…

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Generic Drugs Regulation Drugs 98

Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia.

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BioSpace

AUGUST 30, 2023

Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.

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FDA Approval Generic Drugs Drugs Regulation 91

Camargo

NOVEMBER 11, 2020

Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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Development Bioequivalency Generic Drugs Production 242

World of DTC Marketing

JUNE 22, 2022

The company has hired former senior health regulators to help it navigate America’s healthcare bureaucracy. . Then there is the cost of generic drugs. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm. Generic drugs versus branded is also a considerable expense.

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Pharmacy Generic Drugs Life Science Branding 227

Outsourcing Pharma

OCTOBER 12, 2020

Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.

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Generic Drugs Marketing Drugs Regulation 119

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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Generic Drugs Branding Regulation Manufacturing 105

Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications.

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Pharmaceutical Technology

AUGUST 12, 2022

This trade has been able to continue for the most part, as the UK’s regulator (the MHRA) remains aligned in many areas with the EU’s regulator (the EMA). Even following the Brexit vote, the EU remains the UK’s largest trading partner, and a high proportion of UK drugs originate from European countries.

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Medicine Production Generic Drugs Regulation 290

Pharmaceutical Technology

FEBRUARY 24, 2023

She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation. If you measure everything on faster, I’m not sure Europe will always come out ahead.” Outdated law Whatever the outcome, everyone involved agrees that the legislation needs a makeover. “We

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FDA Law Blog

SEPTEMBER 6, 2023

As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances.

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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

FDA Law Blog

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Generic Drugs Drugs Production Marketing 104

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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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. “You Regulatory applications for generic drugs can be submitted through different pathways , based on their characteristics.

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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Production Generic Drugs Drugs Bioequivalency 52

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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Pharmaceutical Technology

NOVEMBER 29, 2022

The drug is also known for its illegal recreational use. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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Outsourcing Pharma

OCTOBER 5, 2021

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations.

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Generic Drugs Manufacturing Drugs Regulation 52

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

Pharma in Brief

NOVEMBER 5, 2023

201/96 under the Ontario Drug Benefit Act ( ODBA Regulations ). 935 under the Drug Interchangeability and Dispensing Fee Act ( DIDFA Regulations ). In both Regulations, the new exception would apply where the drug product is “not a new drug as defined in the Food and Drug Regulations ”.

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Drugs Regulation Production Generic Drugs 52

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 29, 2021

The drugmaker specialises in selling generic drugs that are hard to manufacture, which places a barrier to widespread generic competition. The regulator said that in addition to the fines, the NHS may choose to pursue the companies for damages in the courts. ” Advanz itself was directly fined £40.9 million and £51.9

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Pharma in Brief

APRIL 29, 2021

Therefore, the new prohibition provided a “humanitarian exception” which allowed financial support to continue in cases to be determined by regulation. Notably, the coming into force of the prohibition was suspended pending the adoption of such regulation. 2] Both the prohibition and the regulation came into force on April 15, 2021.

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Manufacturing Drugs Regulation Branding 52

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

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. The report says the infrastructure around regulators vendors and the support industry will have to significantly change.

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pharmaphorum

JUNE 8, 2021

But we are glad to see the situation for innovative drugs in Asian markets improving, especially in mainland China and South Korea, where policies, societies and regulations are actively promoting innovation. “At In addition, the pharmaceutical industry in China is still heavily dependent on generic drugs.”.

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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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Drugs FDA Approval Generic Drugs Branding 61

FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What? We can offer our readers a special discount for the event.

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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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Regulation Drugs Production Generic Drugs 45

FDA Law Blog

AUGUST 4, 2022

Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking place September 21-22, 2022, in Chicago!

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Generic Drugs Branding Regulation Drugs 40