With Two Business Days Remaining in July, OGD has Only Approved 17 ANDAs
Although Office of Generic Drugs (OGD) total activity numbers (including issuance of Complete Response Letters (CRLs), etc.) will not be posted until about 2 weeks after the close of the month, it is disappointing that the number of approvals this late in the month appears only in the teens.
While there are many things going on at OGD (training of new staff, Guidance and Policy development, the reorganization to a Super Office, among other important things) the bottom line for industry is the number of approvals that OGD issues and the number and timeliness of OGD deficiency responses it receives. But approvals rule the roost in terms of industry importance because, after all, you cannot sell products that receive CRLs.