Advarra

JUNE 6, 2022

Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. A: The webinar discussed the following factors: Conduct a thorough assessment of each site’s QMS. A: That is a tough one. First, congratulations on realizing such a mindset may exist.

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Agency IQ

MARCH 1, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Consultations are held to allow interested parties to contribute to this process.

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Agency IQ

MAY 31, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. regulation, directive, decision). regulation, directive, decision).

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Agency IQ

AUGUST 2, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).

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Agency IQ

AUGUST 30, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars and meetings. food packaging, kitchen and tableware and food processing equipment).

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Agency IQ

OCTOBER 27, 2023

This ongoing feature compiles public information from across the EU to deliver an overview of all the chemical policy-related actions in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).

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Agency IQ

SEPTEMBER 29, 2023

agencies and institutions to deliver insight into what chemicals-related regulatory actions are likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment). which concluded its position on the proposal last June.

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Agency IQ

JANUARY 4, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).

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Regulations Packaging Production Government 40

Agency IQ

DECEMBER 1, 2023

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).

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Agency IQ

FEBRUARY 2, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 23, 2024

By Laura DiAngelo, MPH | Aug 22, 2024 10:13 PM CDT Intro: Pre-Determined Change Control Plans in medical device regulation Post-market updates to authorized medical devices may, or may not, require a new submission to the FDA. This trio of documents are known collectively as the Modifications Guidance documents.

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Agency IQ

APRIL 12, 2024

In an effort to further explain its current views on potency assurance, the FDA also recorded a webinar to accompany the new draft. In particular, potency has played a central role in some of the agency’s recent decisions to issue clinical holds or deny marketing approval. Should potency assurance plans be submitted? If so, how?

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Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

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FDA Science Regulations Biosimilars 40

The Pharma Data

MAY 13, 2021

The way this was done, was through webinars. I know you may be asking, “What is a webinar”? A webinar is an online video presentation that is focused on great practical information which you sit back and view on your PC, Mac, iPod or iPad. Plus, most webinars you canâ??t I was at a fitness site and watched a free webinar.

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Agency IQ

AUGUST 2, 2024

Major European regulators, national competent authorities, and interest groups are planning on hosting several webinars and trainings throughout August and September. Speaking of policy, legislative affairs will also likely pick up.

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Regulations Clinical Trials Production Trials 40

Agency IQ

MAY 31, 2024

Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package.

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Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

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Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

Start Date End Date Event Event Type Center 04/29/2024 04/29/2024 Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series Town Hall CDRH 04/30/2024 04/30/2024 Webinar – Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act Webcast CDRH 05/01/2024 05/01/2024 (..)

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

In a note to clients, RBC Capital Markets analyst Brian Abrahams called the magnitude of the protection CD388 displayed as “exceeding” the firm’s “best case scenario.”

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Drugs Virus Therapies FDA 264

Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. Prohaska, Kavita C.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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Agency IQ

MARCH 29, 2024

EPA also held a public webinar to provide an overview of the TSCA risk management process including the findings in the Part 1 risk evaluation. In addition, EPA published a notice of data availability on March 17, 2023 to solicit public comments on additional data received by EPA related to the proposed rule.

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Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. EPA also held a public webinar to provide an overview of the TSCA risk management process including the findings in the Part 1 risk evaluation.

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BioPharma Drive: Drug Pricing

JUNE 12, 2025

While the current draft of the budget reconciliation package does not include a fix for the pill penalty, we remain encouraged that there are still viable legislative vehicles to address this issue in the near term,” John Stanford, founder and executive director of Incubate, told PharmaVoice.

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