Newsletter - September 6, 2018
FDA Describes How it Selects Manufacturing Sites for Inspections
It is no secret that FDA cannot inspect all drug manufacturing sites, so it prioritizes certain kind of sites based on internal selection criteria. But till yesterday, the details of the selection process were not publicly known. Yesterday FDA released its internal policy for selecting and prioritizing drug manufacturing sites for inspections providing a new insight.. Read More
FDA Expands the Parallel Review Program to Private Payors to Expedite Device Access
For the last few years, FDA has allowed device manufacturers to utilize the Parallel Review Program whereby the manufacturers can have both FDA and CMS review the clinical evidence at the same time in support of both the approval by FDA and the coverage by CMS of a new medical device. Read More
FDA Describes How it Selects Manufacturing Sites for Inspections
It is no secret that FDA cannot inspect all drug manufacturing sites, so it prioritizes certain kind of sites based on internal selection criteria. But till yesterday, the details of the selection process were not publicly known. Yesterday FDA released its internal policy for selecting and prioritizing drug manufacturing sites for inspections providing a new insight.. Read More
FDA Expands the Parallel Review Program to Private Payors to Expedite Device Access
For the last few years, FDA has allowed device manufacturers to utilize the Parallel Review Program whereby the manufacturers can have both FDA and CMS review the clinical evidence at the same time in support of both the approval by FDA and the coverage by CMS of a new medical device. Read More
