Oh sweet summer! The tomatoes hang heavy on the vines, hopefully out of reach of greedy little critters. The peaches and plums are deliciously ripe. It is almost time to put in a second batch of basil to keep growing through the autumn months. And sweetest of all, there simply is no traffic and many parking spaces while people are away on their vacations.
For those looking for Part 2 of the posting about FDA regulatory actions related to pre-approval promotion, it will come next week.
And here is a little bit else:
- Approval of New GSK HIV Drug – Last week in the Weekly Roundup we noted the approval of a new HIV test, this week we note the approval of a new HIV treatment. The agency announced approval this week of GSK’s Tivicay – an integrase strand transfer inhibitor that works by interfering with one of the enzymes that HIV requires in order to multiply. According to the release, it is to be taken daily in combination with other antiretroviral drugs.
- Another Recall Involving Compounding – The concerns related to drug compounding have been much in the headlines in the past year or so, leading me to organize a tab on the Eye on FDA blog site dedicated to tracking the developments related to reform around compounding laws. The agency announced on August 11 a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding due to reports of a potential connection to bacterial bloodstream infections. It is also noteworthy for FDA watchers who wonder if weekend press releases are issued by FDA – this one came out on a Sunday.
- Questions About Medical Foods? Medical foods is one of those areas where I have always been a little fuzzy – like a dandelion at the end of summer. FDA is here to provide a puff of wind to alleviate the fuzziness with the update of a draft guidance serving up a healthy portion of Q&A about medical foods. So if you are like me, you will want to click on this link to get to the newly updated Draft Guidance of Medical Foods.
Well partners, I am going to mosey off to the weekend now. You do the same and have a good one.
