Transdermal drug delivery is a method of delivering medication through the skin to achieve systemic effects.

In the European Union (EU), Compassionate use is a treatment option that allows the use of an unauthorised medicine.

Here are the open status categories for FDA postmarketing requirements and commitments listed.

PAES, as mandated by EU Commission Delegated Regulation No 357/2014, refers to an efficacy study required by a Competent Authority under any of the specified conditions outlined in the regulation.

Rolling Review is a process used by the US Food and Drug Administration (FDA) to expedite the review of new drug applications.

The term 'postmarketing requirement' (PMR) refers to mandatory post-approval studies or trials, including those mandated by the FDAAA, 21 CFR part 314 subpart H, 21 CFR part 601 subpart E, the Pediatric Research Equity Act, and the Animal Efficacy Rule.

Serious risk means a risk of a serious adverse drug experience.

Guillain-Barré syndrome (GBS) is a rare disorder in which a person’s own immune system damages the nerve cells, causing muscle weakness and sometimes paralysis.

Protein amidation is the process through which a carboxyl group is converted into an amide group.

The emergence of oligonucleotide drugs makes it possible to actively design drug sequences to target and silence disease genes.

Site-directed mutagenesis is a molecular biology technique that is used to make specific and intentional changes to the DNA sequence of a gene and any protein that it may encode.

Oligonucleotide drugs are a class of medications that are composed of short, synthetic pieces of DNA or RNA known as oligonucleotides.