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. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Alta Sciences

AUGUST 15, 2023

Sterilization also takes place after formulation, once the product has been filled into the primary packaging, making it the optimal choice. Learn more about our expertise and find out if terminal sterilization is suitable for your product. Speak with one of our experts.

Packaging 40

Packaging FDA Production Drug Development 40

Agency IQ

MAY 3, 2024

Many of these are webinars and/or trainings sessionsfor new digital platforms. The pharma reform package remains in E.U. voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. On April 10, the E.U. On April 10, the E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. A: Yes, the EUA is just temporary. A: This does not usually happen.

Packaging 52

Packaging FDA Trials Regulations 52

Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER. and the E.C.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

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. The Pharmaceutical Research and Manufacturers of America (PhRMA) also voiced this concern, asking the FDA to provide “additional detail regarding phase appropriate implementation.”

Production 40

Production FDA Therapies Biochemical Assays 40

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.

Regulations 40

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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

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?

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA 40

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 (..)

FDA 40

FDA Science Regulations Clinical Trials 40

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

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.

Regulations 40

Regulations Compliance Production Government 40

BioPharma Drive: Drug Pricing

JUNE 23, 2025

According to a report from BioCentury , FDA Commissioner Martin Makary is considering naming former pharmaceutical executive Karim Mikhail, who he recently hired as a senior adviser. Makary is currently conducting a “ listening tour ” with two of his top deputies to meet with pharmaceutical and biotechnology company executives.

FDA 149

FDA Drugs Therapies Licensing 149

BioPharma Drive: Drug Pricing

JUNE 12, 2025

The law made it less likely for pharma companies to pursue more rare disease indications, according to industry groups such as the National Pharmaceutical Council. Plus, the package would require all rebates or discounts received by PBMs to be passed on to a Medicare Part D plan sponsor, according to a recent brief by Mintz.

Small Molecule 130

Small Molecule Packaging Therapies Pharmacy 130

Agency IQ

JANUARY 4, 2024

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.

Regulations 40

Regulations Government Compliance Science 40