The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Drugmakers are pushing back against Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration (TGA) to allow authorized persons to release batches without access to the product’s complete marketing application. Read More
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says. Read More
The flurry of FDA guidance issued this week explaining to compounders how to work with the FDA is part of the agency’s full-on effort to make registration as appealing as possible to compounders who may worry that regulatory oversight will hamper business. Read More
In an effort to head off one of the most common problems that sidetracks ANDA submissions, the FDA is telling drugmakers that bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel. Read More
While developers of next-generation heart drugs known as PCSK9 inhibitors will need to present data showing their effectiveness at lowering cholesterol, blood pressure and inflammation, they will not be required to show reduced heart attack or stroke, according to the FDA. Read More
With EU lawmakers and the European Council expected to reach a compromise on clinical trial regulations before Christmas, pharma, researchers and patient groups are asking for assurance that timelines for trial data submissions are predictable and no longer than timelines currently in force. Read More