Regulatory

Oct 19, 2018
BioPharm International
To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.
Oct 16, 2018
By BioPharm International Editors
The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.
Oct 16, 2018
By BioPharm International Editors
The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.
Oct 16, 2018
By BioPharm International Editors
The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.
Oct 05, 2018
By BioPharm International Editors
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.
Oct 04, 2018
By BioPharm International Editors
Insmed’s Arikayce (amikacin liposome inhalation suspension) is the first drug approved under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs, established to support development of antibiotics for unmet medical needs.
Oct 01, 2018
BioPharm International
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
Sep 28, 2018
While food, shelter, and clothing are the primal essentials for life, hope—as embodied by modern medicine—has now become part of that human expectation.
Sep 28, 2018
By BioPharm International Editors
As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.
Sep 27, 2018
By BioPharm International Editors
The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.
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