DrugBank

SEPTEMBER 12, 2024

Designed with your needs in mind, the DrugBank Data Dictionary addresses this challenge by providing comprehensive documentation for every table and column in our knowledgebase. Together, let’s leverage the power of well-defined, transparent data to accelerate innovation in drug research and development.

Production 78

Production Government Packaging Research 78

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.

Regulations 40

Regulations Clinical Trials Production Trials 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. The final package, though, may well continue its focus on patient access and affordability.

Marketing 40

Marketing Regulations Biosimilars Drugs 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 a study of more than 12,000 small molecule drugs , researchers found 40.4% nitroso-propranolol, nitroso-quinapril, etc.)

FDA 40

FDA Science Production Regulations 40

Agency IQ

NOVEMBER 27, 2023

The update also includes some restructuring as well as changes to two items in the nitrosamines Q&A document. 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.

Regulations 40

Regulations Production FDA Packaging 40