The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5

Packaging 52

Packaging FDA International Pharmaceuticals 52

Agency IQ

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

Regulations 40

Regulations Packaging Compliance Production 40

Agency IQ

SEPTEMBER 6, 2023

This impact was apparently enough for the FDA and generic pharmaceuticals industry to include a new meeting type in the most recent iteration of the Generic Drug User Fee program (GDUFA), called a “Post-Warning Letter Meeting.” In FY2025, that will increase to a goal of 70%, and in FY2026-2027, it will increase to 80%.

FDA 40

FDA Packaging Drugs Pharmaceuticals 40

Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. In other words, the European pharmaceuticals industry could find itself directly affected rather than indirectly impacted through the supply chain.

Pharmaceuticals 40

Pharmaceuticals Regulations Production Pharmaceutical Companies 40

Agency IQ

MAY 17, 2024

GDUFA III), which reauthorized the program through 2027. Two items should be submitted concurrently to the FDA by sponsors seeking a PSUB meeting: 1) the actual meeting request and 2) the meeting package. The first hypothetical involved a topical gel product with two active pharmaceutical ingredients (APIs).

Science 40

Science FDA Drugs Production 40

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40