DrugBank

SEPTEMBER 12, 2024

Data Exploration If you’re venturing into a new area of drug research, the Data Dictionary helps you identify relevant data fields and understand their context. Together, let’s leverage the power of well-defined, transparent data to accelerate innovation in drug research and development.

Production 77

Production Government Packaging Compliance 77

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 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

AUGUST 11, 2023

In September 2020, the FDA issued guidance entitled “Control of Nitrosamine Impurities in Human Drugs,” and later revised the same document in February 2021 to extend certain deadlines. In 2014, The International Council on Harmonisation ( ICH) M7 Guideline harmonized regulatory approaches to address genotoxic impurities.

FDA 40

FDA Science Production Regulations 40

Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. s international competitiveness.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Biomedical sciences have been criticized as “ an internally self-consistent universe with little contact with medical reality.”

Laboratories 117

Laboratories Research Disease Science 117