The latest update from the FDA has brought 43 new and updated product-specific guidances for generic drug development, including dedicated documents on complex generics such as aerosols, powders and sprays.
The latest update from the US Food and Drug Administration in early March has brought 43 draft new and updated product-specific guidances for generic drug development, comprising 33 new guidances and 10 revised documents.
Among the latest documents are new draft guidances dedicated to besifloxacin hydrochloride suspension and clevidipine emulsion, as well as...
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.
Generics Bulletin reviews global regulatory developments across the world.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.
Generics Bulletin reviews global regulatory developments across the world.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
