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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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

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. Manager of Regulatory Compliance. Co-Authors: Jenny Fielder.

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Development Bioequivalency Generic Drugs Production 242

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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FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M. Clinical Trials.

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Compliance Clinical Trials Clinical Trials Regulation 59

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As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these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

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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Cosmetics Compliance Generic Drugs Regulation 59

XTalks

AUGUST 30, 2022

Due to consistent changes in pharmaceutical regulation, pandemic-related disturbances and the ongoing effects of digitization, visionary leaders could find themselves co-constructing their vision. Public health and regulatory compliance entities depend on bureaucratic leadership to run effectively.

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Life Science Generic Drugs Drug Delivery Compliance 105

Pharma Marketing Network

FEBRUARY 27, 2025

But how can pharma marketers maximize their PPC campaigns while staying compliant with strict regulations? Lets explore the best PPC strategies for pharma brands and how they can improve brand awareness, lead generation, and return on investment (ROI). Provide relevant, engaging content (not just a generic drug page).

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Branding Marketing Compliance Engineer 52

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

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Drugs Manufacturing Medicine Regulation 71

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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FDA Approval Marketing Branding Generic Drugs 52

pharmaphorum

JULY 28, 2022

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. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease. The stakes are high.

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Compliance Drugs Manufacturing Generic Drugs 111

Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Regulation Manufacturing Drugs Medicine 52

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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FDA Approval Production Drugs Generic Drugs 40

Drug Patent Watch

FEBRUARY 20, 2025

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses. Share your thoughts in the comments below!

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Generic Drugs Drugs Manufacturing Compliance 96

Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development. The generic drug development process involves several stages, from patent research to regulatory approvals.

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Pharma Marketing Network

MARCH 12, 2025

In a highly regulated industry, choosing the right keywords can determine whether your ads reach healthcare professionals, patients, or caregivers effectively. Without precise targeting, ad spend can be wasted on irrelevant searches, reducing conversion rates and compliance effectiveness. Understanding Pharma-Specific PPC Challenges 1.

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Pharma Marketing Network

FEBRUARY 27, 2025

With increasing competition, strict regulations, and changing consumer behavior, pharmaceutical brands must embrace digital transformation to stay relevant. Unlike traditional marketing, digital marketing allows brands to engage with HCPs and patients in real time while maintaining compliance with industry regulations.

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Branding Marketing Compliance Regulation 52

Pharma Marketing Network

NOVEMBER 24, 2024

The rise of generic drug competitors, stringent regulatory environments, and increasingly empowered patients mean one-size-fits-all approaches no longer work. Navigating Regulatory Compliance Pharmaceutical advertising operates under strict regulations. Non-compliance can cost dearly.

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Sales Marketing Compliance Branding 52