Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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ACRP blog

FEBRUARY 11, 2025

The Health Care Compliance Association (HCCA), a nonprofit membership organization supporting healthcare compliance professionals, was founded, in part, to be your eyes and ears for compliance updates and regulatory changes. Group discounts are available; bring your team for shared learning!

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Bio Pharma Dive

JUNE 20, 2024

RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.

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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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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. Right now, it’s compliance by checkbox, in a static way.

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Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable.

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Camargo

NOVEMBER 11, 2020

The ANDA application must contain a basis of submission specifying the RLD, and the applicant must show that the proposed generic drug is the same as the RLD with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics. Co-Authors: Jenny Fielder.

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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.

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FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. After his remarks, Mr.

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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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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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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., Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments.

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Camargo

SEPTEMBER 8, 2021

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. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA.

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FDA Law Blog

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Hyman, Phelps & McNamara, P.C.

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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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Camargo

MAY 10, 2021

The guidance goes on to generally describes the tools and the mechanics of using the tools for programs, including (but not limited to) Pre-Approval Inspections (PAIs), Pre-License Inspections (PLIs), Post-Approval Inspections (PoAIs), Surveillance Inspections, Follow-Up and Compliance Inspections, and Bioresearch Monitoring (BIMO) Inspections.

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FDA Law Blog

APRIL 8, 2024

In a display of the competition within the generic industry that keeps margins low , this total included 118 new drug applications and 956 generic drug applications. OPQ also worked on 55 novel drug approvals for products with new molecules. The role of technology on quality was another feature.

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Pharma Marketing Network

FEBRUARY 27, 2025

The ability to target based on demographics, interests, location, and behavior makes PPC a game-changer for pharma brands promoting prescription drugs, disease awareness, and patient education resources. PPC provides the tools to navigate compliance while reaching the right audience effectively.

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FDA Law Blog

NOVEMBER 20, 2023

Of note, the new structure removes any separation between new and generic drug quality review offices. The Agency has high expectations of industry’s willingness to invest in and proactively address quality matters. The new parts of OPQ reflect that. It’s also clear that culture counts.

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pharmaphorum

JUNE 3, 2021

The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its label that includes a claim of less weight gain with olanzapine on its own, a big problem with the widely-used generic drug that affects compliance with treatment.

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Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” A majority of inspections resulted in findings of non-compliance. based inspectors who go overseas, 66 remained unfilled.

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Cloudbyz

MARCH 5, 2024

Administration and Dosage: Due to their nature, biologics are often administered via injection or infusion, which can affect patient compliance and convenience. Ensuring batch-to-batch consistency is a significant challenge. Determining the optimal dosage and administration route is more challenging.

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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. The courts also had a busy year in 2021.

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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. Just like it was over a decade ago in Pliva v.

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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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XTalks

AUGUST 30, 2022

The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Public health and regulatory compliance entities depend on bureaucratic leadership to run effectively. Therefore, strategic intent is vital when making decisions.

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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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Drug Patent Watch

MARCH 25, 2025

Breaking into the Generic Drug Market: Strategies for Success As a pharmaceutical professional, you know that the generic drug market is a highly competitive space. With new generic drugs entering the market every year, it can be challenging to stand out from the crowd and achieve success.

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Pharma Marketing Network

MARCH 12, 2025

Without precise targeting, ad spend can be wasted on irrelevant searches, reducing conversion rates and compliance effectiveness. But how do you balance compliance with visibility? Competition for High-Value Keywords Branded drug names and general medical terms attract intense competition. A mix of branded (e.g.,

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Pharma Marketing Network

FEBRUARY 27, 2025

Unlike traditional marketing, digital marketing allows brands to engage with HCPs and patients in real time while maintaining compliance with industry regulations. Drive prescription intent by educating HCPs about the latest drug advancements. Ensure compliance while leveraging digital tools for outreach.

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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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