Biotechnology Industry Organization

PhRMA speaks out against FDA biosimilar flexibility

30-Apr-2012 By Nick Taylor

PhRMA has spoken out against FDA plans to allow biosimilar manufacturers flexibility in delivery device and formulation choice.

Amgen warns biosimilar draft a threat to production innovation

25-Apr-2012 By Nick TAYLOR

Amgen has told the FDA that draft biosimilar guidance risks inhibiting manufacturing improvements and burdening industry.

Top 5 podcasts, interactive visualisations & videos of 2010

20-Dec-2010 By Nick Taylor

in-PharmaTechnologist presents five of our top audio-visual articles of 2010, including a map of Pfizer’s plant closures, gangsters in the pharma industry and a look inside SAFC’s HPAPI plant.

FDA pandemic guidance is “unnecessarily burdensome”

16-Mar-2010 By Nick Taylor

GSK, Genentech, BIO and PDA have stated that it is “unnecessarily burdensome” for pandemic production plans to conform to parts of 21 CFR and requested that the FDA revises its draft guidance.

FDA publishes final rule on cGMP amendments

09-Sep-2008 By Nick Taylor

The US Food and Drug Administration (FDA) has published its latest amendments to current good manufacturing practice (cGMP) regulations.