How The EU Adopts Its Regulations
EU Regulations, just like Directives, are adopted through what is known as the ordinary legislative procedure (which replaces the former co-decision procedure). The process starts with the European Commission drafting a text and submitting it to the European Parliament and Council of the European Union (this step is usually preceded by a public consultation).
You may also be interested in...
The EU’s medical device regulatory structure, first devised over 20 years ago, is starting to change. The first major revision of directives will produce a tougher environment and require medtech manufacturers to make some significant adjustments.
The Committee on Energy and Commerce of the US House of Representatives has requested a set of documents from the FDA in order to assess whether the agency is doing enough to address the challenge of approving complex generics within its existing authorities, or whether additional authority is needed.
As industry bellwether J&J kicked-off 2019 fourth-quarter and full-year earnings season for life sciences companies, its financial results left investors feeling the cold. But with coronavirus envy sweeping a raft of smaller biotech companies, J&J may have the last laugh.