FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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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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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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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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Pharmaceutical Technology

MARCH 10, 2023

The list also includes manufacturers and suppliers of biological safety cabinets, clean benches, nanotechnology enclosures, drying chambers, vacuum pumps, filters, remote blowers and exhausters, loading and unloading systems as well as controlling and monitoring systems.

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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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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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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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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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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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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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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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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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Pharmaceutical Technology

JUNE 24, 2022

The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 The EMA stated that the agency will initially focus on the chemistry, manufacturing and controls (CMC) data for the component targeting Omicron subvariants. In addition to providing protection against the Omicron BA.1

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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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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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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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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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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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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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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).

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Packaging Packaging Containment Production 98

XTalks

APRIL 4, 2022

Last week, Hormel Foods announced a voluntary food recall of 9,353 cases (or about 60,000 jars) of Skippy peanut butter over concerns that a “limited number” could contain stainless steel fragments from an errant piece of manufacturing equipment. The manufacturing facility’s internal detection systems identified the concern.”.

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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.

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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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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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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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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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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. About Sensorion.

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Gene Therapy Gene Manufacturing Production 52

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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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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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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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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XTalks

MARCH 30, 2023

If passed, the bill would make California the first state to ban the sale and manufacture of foods containing titanium dioxide, among other chemicals and dyes. A handful of US food chains, including Panera Bread , have already outpaced regulators, announcing they will no longer sell products that contain the ingredient.

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FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

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FDA Law Blog

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

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FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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