FDA to Begin GMP Inspections Next Week, Sort of.

FDA announced earlier this week that the domestic GMP inspections would commence on Monday, 20 July. However, there would still be several conditions that must be met before FDA inspectors travel to a manufacturing site and FDA would allow several concessions to the site being audited such as no-unannounced visits, using PPEs during the visit … Read more

Covid Vaccine Will be The “October Surprise” One Way or the Other

With the announcement of positive results from a small clinical trial for its experimental Covid vaccine this week, Moderna set the stage for what to expect in the next 2-3 months. Moderna may be in the news more than others, but others are not behind. Oxford-Astra Zeneca announced the start of a 10,000 patient multi-national … Read more