Krieger Scientific founder Joseph Morwald says a surge in FDA drug Warning Letters is driven by an industry systemic problem that is being ignored rather than by individual mistakes.
FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with Bristol Myers Squibb's Opdivo, for treating certain adult patients with unresectable advanced cutaneous melanoma.
Krieger Scientific founder Joseph Morwald says a surge in FDA drug Warning Letters is driven by an industry systemic problem that is being ignored rather than by individual mistakes.
FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with Bristol Myers Squibb's Opdivo, for treating certain adult patients with unresectable advanced cutaneous melanoma.
FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.
The International Medical Device Regulators Forum releases a final document outlining global principles for Predetermined Change Control Plans for updates to medical device software.
