Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S.

FDA 40

FDA Disease Regulations Production 40

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.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Packaging 59

Perficient: Drug Development

JULY 29, 2024

Security is a crucial aspect of any application, especially when dealing with sensitive information such as passwords. Setting Up Encryption and Decryption We’ll use the javax.crypto package in Java, which provides the necessary classes for encryption and decryption. Selenium WebDriver library added to your project. getEncoder().encodeToString(encryptedPassword);

Packaging 52

Packaging Compliance Regulations 52

The Premier Consulting Blog

MAY 4, 2023

The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. Therefore, the FDA will examine product classifications, especially for those products that have been regulated as drugs even though they may satisfy the device definition.

FDA 52

FDA Packaging Compliance Regulations 52

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. On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA.

Regulations 40

Regulations Packaging Production Government 40

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.,

Compliance 40

Compliance Regulations Packaging Production 40

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. Additional information responses for an MDR were also encouraged to be submitted electronically. Either way, the information is transmitted to FDA via the ESG.

Packaging 59

Packaging FDA Production Regulations 59

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.

Regulations 40

Regulations International Packaging Compliance 40

Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Packaging 40

Packaging Regulations Production Compliance 40

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.

Small Molecule 102

Small Molecule Government FDA Approval Regulations 102

Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

Agency IQ

MAY 10, 2024

The VDEQ will require a facility disclose its manufacture or use of PFAS, the chemical names and CAS RNs of specific substances, the amount of PFAS manufacture or used in the preceding 12 months, and “ any additional information reasonably required by the Department to ascertain sources and quantities of PFAS manufactured or used.”

Packaging 40

Packaging Regulations Production Compliance 40

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. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.

Regulations 40

Regulations Packaging Production Doctors 40

The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. The sponsor then submits a request packet to CMS containing the following information: [3] A request letter describing the scope and nature of the IDE study.

Regulations 52

Regulations FDA Clinical Trials Packaging 52

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

FDA 40

FDA Regulations Packaging Marketing 40

The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Related Information. Today, the U.S. We will continue to work to protect consumers.”. 29 and Sep.

Production 52

Production FDA Packaging Regulations 52

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.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. By Philip Won & Adrienne R. But that is only the beginning.

FDA 75

FDA Packaging Laboratories Engineering 75

Agency IQ

SEPTEMBER 6, 2023

But as a new guidance document clarifies, the FDA need to receive certain information from companies to make this meeting type work, and its not in a rush to receive requests, either. Any information to be discussed at the meeting must be submitted to FDA 60 days in advance of the meeting.

FDA 40

FDA Packaging Drugs Production 40

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. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

FDA 40

FDA Regulations Production Packaging 40

Advarra

JULY 19, 2022

For more information on key components of a fit-for-purpose, phase-by-phase QMS guidance download Advarra’s whitepaper Steps to Implementing a Quality Management System. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records. Q: What must be done to prove oversight?

Packaging 52

Packaging FDA Trials Regulations 52

Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

Regulations 40

Regulations International Government Compliance 40

The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., The drug product is packaged and shipped as a solid powder. While this meeting is optional, it often yields time-saving information.

Production 52

Production Efficacy & Potency Packaging FDA 52

Agency IQ

JUNE 28, 2024

This AgencyIQ analysis reviews several recent developments in state PFAS legislation and how it will inform future legislation. Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues.

Production 40

Production Regulations Compliance Packaging 40

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. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

FDA 40

FDA Science Regulations Clinical Trials 40

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . In a separate Research Letter, Simon J.

Research 52

Research FDA Approval Drugs FDA 52

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. . The IND goes into effect; and .

Clinical Trials 52

Clinical Trials Trials FDA Regulations 52

FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA regulations, at 21 C.F.R. The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. patients in harm’s way.” FDA responded in late July, denying Vanda’s petitions.

FDA 40

FDA Production FDA Approval Regulations 40

Advarra

JUNE 28, 2022

There are a myriad of regulations coming into play during the drug development process. Because of this, the FDA understands sponsors may need help making sense of regulations. Too Much Data or Unnecessary Information. Conversely, failing to present the information concisely is a major flaw.

FDA 52

FDA Regulations Clinical Trials Packaging 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

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. That brings us to the product’s approval.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

Clinical Trials 52

Clinical Trials Clinical Research Trials Hospitals 52

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.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

To request a meeting, the facility must submit a meeting package with specified information about the facility; information about the suggested meeting; a list of topics requested to be addressed during the meeting; and, perhaps most critically, information about corrective actions that have been taken or are in progress to address the deviations.

FDA 45

FDA Drugs FDA Approval Packaging 45

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. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

Regulations 40

Regulations Production Packaging Compliance 40

Agency IQ

DECEMBER 15, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation. for uses under TSCA.

Packaging 40

Packaging Regulations Government Production 40