Agency IQ

AUGUST 30, 2024

By Scott Stephens, MPA In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. Fill out the form to read the full article.

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Agency IQ

JUNE 28, 2024

Why comprehensive state-level bans on PFAS in products are faltering Despite a wide array of bans on per- and polyfluoroalkyl substances (PFAS) progressing through state legislatures, even the planning around the implementation of some of these efforts has led the legislatures to amend or abandon the bans.

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The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., The drug product is packaged and shipped as a solid powder.

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Cytel

OCTOBER 23, 2023

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the two main divisions of the FDA responsible for regulating drugs and biological products, as well as combinations of drugs and biological products.

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The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Families rely on stores like Family Dollar for products such as food and medicine.

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Production FDA Packaging Regulations 52

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 25, 2023

As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. PFAS regulation in the E.U. Two high-profile initiatives to regulate PFAS in the E.U. years for products like industrial precision cleaning fluids to 6.5

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biobide

NOVEMBER 20, 2023

The justification for this growth projection lies in the increased popularity and demand for skincare and personal care products, joined by the aging of global population. Such concerns have led to strict regulations regarding the formulation of cosmetic products.

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The Premier Consulting Blog

MAY 4, 2023

Given this trend, many biopharmaceutical companies are investing in strategies to develop and commercialize new or existing ophthalmic products that address unmet medical needs. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

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FDA Law Blog: Biosimilars

JUNE 26, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). not subject to premarket review).

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Drug Target Review

AUGUST 7, 2024

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

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Agency IQ

FEBRUARY 23, 2024

The historical ubiquity of PFAS in consumer products means it is frequently released into the environment as well. PFAS have been used in a wide variety of consumer products, often for their ability to repel both water and oil. In 2019, the state began to significantly ramp up its PFAS regulation and research. with the U.S.

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Agency IQ

JULY 12, 2024

EPA grants petition on PFAS in fluorinated containers Following a loss at the Fifth Circuit, the EPA has a new plan to regulate PFAS in fluorinated plastic containers: traditional Toxic Substances Control Act Section 6 rulemaking. EPA issued the order under TSCA section 5 authority.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

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Agency IQ

MAY 10, 2024

The historical ubiquity of PFAS in consumer products means it is frequently released into the environment as well. PFAS have been used in a wide variety of consumer products, often for their ability to repel both water and oil. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

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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. Source link.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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The Pharma Data

JULY 11, 2021

A separate analysis of patients with moderate to severe UC evaluated meaningful improvement of bowel urgency, a common symptom of UC that is associated with higher levels of disease activity, decreased work productivity and worse quality of life. ” Patients with UC Reported on Definition of Meaningful Change in Bowel Urgency.

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Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. PFAS have been used in a wide variety of consumer products, often for their ability to repel both water and oil.

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Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. REACH, CLP, BPR, PIC), scopes (e.g.,

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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

8 What these disease-causing products—including the highly refined foods that contribute to obesity— have in common is that they activate the brain’s reward system in ways that are highly reinforcing. The cannabis industry has presented new opportunities for commercial interests to drive drug consumption across all ages and demographics.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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PPD

OCTOBER 18, 2023

However, an effective CRO doesn’t just perform assays; it provides comprehensive project planning, and also compiles, analyzes and packages data into an actionable and appropriate format for each individual client. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money.

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Agency IQ

JUNE 7, 2024

European Commission issues EU-wide rules on pesticide ingredients The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU.

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Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Group 1 for disinfectants contains five product-types. Product-type 2 encompasses disinfectants applied to surfaces.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Through rebadging, sponsors can maintain continuity on key development programs while avoiding costly severance packages and payouts. PPD FSP solutions can help.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

It is not especially novel even within CBER, as previous publications had encouraged the use of standards in product development. FDA needs assurances regarding the safety, purity, and potency of regenerative medicine products to approve them.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . 21 CFR 312.40(a) b)(1) )

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The Premier Consulting Blog

NOVEMBER 16, 2022

One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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