Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.

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Cloudbyz

APRIL 25, 2023

A vital aspect of pharmacovigilance is regulatory reporting, which facilitates effective communication between pharmaceutical companies, medical device manufacturers, and regulatory authorities. Compliance: Adhering to the regulatory requirements for safety reporting is vital for maintaining compliance and ensuring patient safety.

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Pharmaceutical Technology

APRIL 26, 2023

The conceptualisation, development and manufacturing of primary packaging in the pharmaceutical industry require a meticulous and multi-disciplinary approach to ensure that the products meet the highest standards of safety and efficacy.

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Packaging Packaging Manufacturing Development 130

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. On top of this, some regulations have changed, plunging more facilities into the possibility of not complying. Doing so means that businesses can check their compliance before an FDA inspection.

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Drug Patent Watch

DECEMBER 11, 2024

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs). Transparency Regarding Costs Understanding the costs associated with working with a CDMO is crucial.

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Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Proposed FDR Amendments Create Imbalance in Linkage Regime.

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XTalks

JULY 26, 2024

In today’s rapidly evolving food industry, enterprise resource planning (ERP) systems for food manufacturers are essential. They ensure efficiency, compliance and profitability. Wherefour , a leader in ERP solutions, is transforming and simplifying how food and beverage companies manage production and compliance.

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.

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Regulation Compliance Medicine Manufacturing 52

FDA Law Blog

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. Generally speaking, that recognition has limits, however.

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XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

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XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Pharmaceutical Manufacturing and Supply Chain Changes.

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Manufacturing Clinical Trials Clinical Trials Production 89

XTalks

AUGUST 12, 2024

Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health. These may range from working with manufacturers to reduce lead levels to restricting the distribution of affected products in the US market.

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Contamination Compliance Regulation Production 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.”. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. Final Regulation Issued for “Intended Use”.

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Pharma Packaging Solutions

OCTOBER 29, 2024

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. International Standards and Classifications Compliance doesn’t end with the EU GMP certifications.

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Drug Patent Watch

DECEMBER 30, 2024

The PMDA evaluates the generic drug based on its chemical, physical, and biological characteristics, as well as its manufacturing process and quality control measures. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Pharmaceutical Regulations in Japan 2020. Freyr Solutions.

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pharmaphorum

DECEMBER 28, 2022

In turn, the acquiring company will help the novel drugs navigate the complexities and costs of regulations and benefit from market access and economies of scale. These teams will include experts in regulatory, GMP compliance and quality systems, often including ex-FDA and MHRA inspectors and industry experts.

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Compliance Regulation Manufacturing Licensing 119

Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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Manufacturing Regulation Compliance Production 98

XTalks

FEBRUARY 26, 2024

Key developments in food regulations in 2024 are expected, focusing on safety, transparency and public health. For stakeholders in the food industry, understanding and adapting to these regulations is not just a matter of compliance but a strategic imperative for business success.

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FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. (We

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Manufacturing Regulation Compliance Marketing 98

Camargo

NOVEMBER 15, 2021

FDA Publishes ICH Guidelines on Continuous Manufacturing. The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.” A process to manufacture tablets utilizing continuous feeding, blending, and tablet compression, followed by a batch-mode film coating.

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FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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Regulation Compliance Manufacturing Packaging 52

XTalks

APRIL 16, 2024

Related: FDA Food Regulations 2024: Navigating the Changing Landscape Interacting with seasoned experts provides a unique opportunity to benchmark and elevate an organization’s food safety practices. Understanding and implementing new regulations is paramount in maintaining safety standards and protecting public health.

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Regulation Compliance Allergies Manufacturing 105

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. For instance, CAPA in good manufacturing practices (GMP) addresses manufacturing deviations and quality deficiencies.

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Compliance Clinical Development Development Clinical Trials 52

FDA Law Blog

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. By Steven J.

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Compliance Regulation Drugs Manufacturing 52

FDA Law Blog

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. Thus, these regulations apply to a huge variety of products.

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Radiology Regulation Manufacturing Production 52

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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Pharmacy Manufacturing Drugs Regulation 59

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. By Adrienne R. Design controls (21 C.F.R.

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XTalks

MARCH 7, 2024

Earlier this week, the US Food and Drug Administration (FDA) took a significant step forward in regulating dietary supplements. This structured approach ensures that industry stakeholders have a thorough understanding of the requirements and procedures, promoting compliance and safety in the dietary supplement market.

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Regulation Manufacturing Marketing Compliance 105

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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Manufacturing Regulation Compliance Production 75

Drug Channels

AUGUST 21, 2020

As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. He argues that greater adoption of the established 340B rebate process will benefit all stakeholders: covered entities, manufacturers, state Medicaid programs, and others.

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Compliance Regulation Manufacturing Drugs 52

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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Pharma in Brief

DECEMBER 3, 2020

Health Canada has published a proposal titled “ Consultation on amending the Food and Drug Regulations ( FDR ) to expedite access to COVID-19 drugs ”. Manufacturers would be required to provide bilingual labelling under certain circumstances. require market authorization holders to meet post-marketing regulatory requirements; and.

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Vaccination Vaccine Drugs Manufacturing 98

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Clinical Research Research Compliance Clinical Trials 52

pharmaphorum

MAY 25, 2022

The move to online international meetings has left pharma companies with uncertainty around contact compliance. They state that when the medicine is not approved in the country of the meeting, companies should refer to the regulations of the “host country”. But new joint guidance, from the IFPMA, EFPIA, and PhRMA, provides clarity.

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Regulation Compliance Manufacturing Medicine 105

XTalks

OCTOBER 12, 2022

Once every two years, food manufacturers must undergo the US Food and Drug Administration (FDA) registration renewal process to ensure and uphold food safety. Agents, owners or operators of food manufacturing facilities must go through the FDA registration renewal process before the deadline. If not, the registration will be rejected.

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FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance.

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