Supporting medicine developers

por Asphalion

6 years ago
EMA, innovative medicines

EMA tools to foster development of new and innovative medicines. The European Medicines Agency (EMA) released a new infosheet that provides regulatory and scientific guidance to foster development of ...

A change that affects every ANDA and 505(b)(2) amendment to an unapproved application

por Asphalion

6 years ago
generic drugs, regulation, ANDA

The Office of Generic Drugs started to send out official correspondence saying that an amendment submitted without a verification statement is deficient, because it is not reflecting a new ANDA sectio...

New IRIS portal will be mandatory for Orphan Drug Designations process

por Asphalion

6 years ago
portal, orphan drug designations, IRIS

The portal is called IRIS and as of 19 September will be the mandatory submission process for Orphan Drug Designations (ODD) applications. It can be used to manage all important ODD activities includi...

Is human plasma used in the manufacture of your products?

por Asphalion

6 years ago
Plasma Master File certification, marketing authorisation, plasma-derived medicinal products

For the marketing authorisation of plasma-derived medicinal products, the plasma master file (PMF) certification is used. The PMF is a compilation of all the required scientific data on the quality, s...

Countdown for FDA Open Seminar 2018

por Asphalion

6 years ago
FDA Open Seminar, regulatory affairs

"FDA Open Seminar: All you need to know!" will provide a structured introduction to all important aspects of FDA Regulatory Affairs, but will also cover current hot topics as well as recent changes in...

Asphalion and Mitelos are organizing the first seminar in US

por Asphalion

9 years ago
Asphalion, Mitelos, seminar, business development, networking

With more than 20 years of experience in the European regulatory environment, our speakers will present the important steps for setting the strategy for successful European submissions