Newsletter - October 19 2017
FDA’s Audit Manual Updated: Surprisingly No Surprising Changes
This week FDA published the updated inspections manual which does not contain any obvious major changes to the previous version. Earlier this year FDA’s Office of Regulatory Affairs was reorganized to improve the quality of inspections. However, the inspections manual does not reflect those changes. Read More
Orphan Drug is Generally Not the First Step to Non-Orphan Approval
About two-thirds of drugs approved as orphan drugs in the last 20 years did not get subsequent approval for other indications, and only 6 orphan drugs out of the 451 approved by FDA ended being top-selling drugs. Conventional wisdom in the industry has been that orphan designation... Read More
FDA’s Audit Manual Updated: Surprisingly No Surprising Changes
This week FDA published the updated inspections manual which does not contain any obvious major changes to the previous version. Earlier this year FDA’s Office of Regulatory Affairs was reorganized to improve the quality of inspections. However, the inspections manual does not reflect those changes. Read More
Orphan Drug is Generally Not the First Step to Non-Orphan Approval
About two-thirds of drugs approved as orphan drugs in the last 20 years did not get subsequent approval for other indications, and only 6 orphan drugs out of the 451 approved by FDA ended being top-selling drugs. Conventional wisdom in the industry has been that orphan designation... Read More
