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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Regulation Medicine Generic Drugs Containment 98

Pharmaceutical Technology

MAY 24, 2023

CGT trials operate with much lower volumes of manufactured final product. CGT have highly unique and specialized manufacturing processes. This implies precise (and frequently changing) timeline planning for drug manufacture and delivery. Most often the CGT patient dose administration is a single dose or limited periodic dose.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

XTalks

MARCH 23, 2022

Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. . “Cholesterol-free,” “low-fat,” “super light,” “sugar-free” or “anti-ageing” are all examples of believable claims on food labels.

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Manufacturing Production Branding Packaging 119

XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Some of these chemicals are known endocrine (hormone) disruptors linked to developmental, cognitive and other health problems in babies and adults.

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Regulation Hormones Containment Packaging 94

Drug Patent Watch

JANUARY 14, 2025

Case Study 1: Overcoming Formulation Challenges Let’s kick things off with a look at how generic drug manufacturers are tackling formulation challenges head-on. Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1]. The bone of contention?

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Generic Drugs Development Drugs Manufacturing 87

Roots Analysis

JANUARY 27, 2025

It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs.

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Manufacturing Contamination Production Gene Therapy 40

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers.

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FDA Approval Manufacturing Development RNA 105

FDA Law Blog

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. By Adrienne R.

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Containment Regulation Manufacturing 59

Camargo

NOVEMBER 15, 2021

In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above. FDA Publishes ICH Guidelines on Continuous Manufacturing.

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Development Manufacturing Production Packaging 187

FDA Law Blog

FEBRUARY 13, 2025

Therefore, this guidance builds on FDAs commitment to develop and apply innovative approaches to the regulation of [AI-enabled devices]. Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment.

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Manufacturing Marketing Development Containment 71

XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. 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.

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Contamination Compliance Regulation Production 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

The list includes suppliers of a wide range of pharmaceutical packaging, containers and containment solutions, including plastic, glass and other customised packaging solutions, as well as labelling and printing solutions. Finding the best commercial packaging suppliers in contract marketing.

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Packaging Packaging Marketing Containment 100

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each module contains six standard sized containers, which measure 2.6

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Vaccination Vaccine Production Manufacturing 105

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

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Production Containment Packaging Packaging 130

FDA Law Blog

JULY 7, 2022

Specifically, FDASLA includes the Modernization of Cosmetics Regulation Act of 2022 proposing significant amendments to the FDC Act, intended to modernize safety standards for cosmetics in the United States. The bill includes certain exemptions for small businesses.

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Cosmetics Regulation Production Manufacturing 52

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. Evolution of the Regulations Coming into force (1993–1997).

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Regulation Compliance Medicine 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. 360ii, 360kk(a)(1), and 360nn(b))).

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Radiology Regulation Manufacturing Production 52

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 22, 2025

As consumer interest in protein-enriched foods continues to grow, food manufacturers are increasingly seeking high-quality, functional ingredients that enhance both nutrition and sensory appeal. This allows manufacturers to create vegan spoonable dressings that offer a similar silky consistency and mouthfeel as traditional versions.

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Protein Manufacturing Production Marketing 52

FDA Law Blog

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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Manufacturing Cosmetics Regulation Containment 105

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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Regulation Production Cosmetics Sales 45

XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements.

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Allergies Manufacturing Contamination Production 98

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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In-Vitro Regulation Manufacturing Licensing 81

Pharmaceutical Technology

FEBRUARY 8, 2023

This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development. Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks.

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Gene Therapy Gene Trials Clinical Trials 264

Camargo

SEPTEMBER 14, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development. The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics.

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Clinical Trials Clinical Trials Medicine Production 144

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. extractables and leachables).

Packaging 98

Packaging Packaging Containment Production 98

XTalks

JANUARY 17, 2023

Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels. We’re about to see a whole new book of regulations come into effect, with FDA labeling being one of the biggest ones,” said Bradley Saxe, President of Mainline Foods, in an interview with Xtalks last year.

Allergies 98

Allergies Packaging Packaging Containment 98

Pharmaceutical Technology

FEBRUARY 16, 2023

The growing demand for higher precision, high-performance, and power-efficient devices and the increasing need for quality control and assurance in manufacturing processes are propelling the growth of analysis and test & measurement equipment in the pharmaceutical industry.

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Engineer Manufacturing Containment Production 130

The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway. Disclaimer.

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Manufacturing Vaccination Vaccine Production 52

XTalks

NOVEMBER 23, 2023

This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing. The scandal led to stricter regulations on pesticide use and a push for organic farming methods.

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Contamination Regulation Bacterium Allergies 103

FDA Law Blog

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA also directed manufacturers to produce detailed marketing plans.

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Production Manufacturing Marketing Regulation 115

The Pharma Data

DECEMBER 15, 2020

Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor’s pharmaceutical products. ” “We look forward to working side by side with Lipidor to be able to offer manufacturing to their future licensees. .”

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Contract Manufacturing Manufacturing Production Drugs 52

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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Compliance Marketing Regulation Development 98

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. The UK government already has an order for 30 million doses with AstraZeneca, which the company has already begun to manufacture at risk ahead of approval.

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Vaccination Vaccine Trials Protein 102

Pharmaceutical Technology

JANUARY 16, 2023

Policymakers are attempting to respond to inflation crises by introducing new frameworks on the regulation of drug prices. The legislation contains several provisions to lower prescription drug costs, including allowing Medicare to negotiate the cost of selected medicines. The entire pharma industry will be affected by the fallout.

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Manufacturing Marketing Production Drugs 162

Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product.

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Development Production Immune Response Licensing 161

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

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Antibody Manufacturing Production Sales 52