Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this 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.

Regulations 40

Regulations Clinical Trials Production International 40

Agency IQ

NOVEMBER 27, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. In a study of more than 12,000 small molecule drugs , researchers found 40.4% guidelines.

Regulations 40

Regulations Production FDA Packaging 40

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. There have been deaths in phase 1 medical and drug research among healthy participants. That's not coincidental.

Vaccine 119

Vaccine Trials Disease Virus 119

Drug Discovery World

MARCH 13, 2023

They can manufacture the drug substance and then pass it to a specialised fill-finish facility that will load it into its final sterile packaging.   Conversely, cell therapy manufacturing starts with a highly heterogeneous source material: human blood. Previously, she also worked at St. Lauren obtained both her Ph.D.

Therapies 130

Therapies Drug Development Clinical Trials Cell Based Assays 130

Agency IQ

AUGUST 11, 2023

drug supply, manufacturers should conclude a risk assessment of approved or marketed products within 6 months of publication of this guidance,” FDA added, with confirmatory testing intended to be concluded within 3 years. Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks.

FDA 40

FDA Science Production Regulations 40