Well, there is definitely a bite of autumn crispness in the air and I think we are on the verge of first frost. The days are noticeably shorter. Daylight savings (always thought it a funny name for it) is upon us very soon when we will Fall Back. There are increasing numbers of leaves tracked into the house. I have begun to think about stews and meat pies instead of creative salads and chilled soups.
And the government is back to work. One can see a whirl of activity out of NIH and CDC electronic streams as well as FDA. So while last week the Roundup went quiet, here it is some of the agency catch-up:
- Move to Reclassify Hydrocodone – The agency issued a statement this week announcing plans for FDA to submit a formal recommendation to HHS to reclassify hydrocodone combination pain products to move to DEA Schedule II. The submission of the recommendation will begin the process for DEA to make a decision. FDA said that it has become “increasingly concerned about the abuse and misuse of opioid products” and noted that abuse had reached epidemic proportions. The agency noted that DEA asked for a recommendation regarding the move back in 2009.
- FDA Opens New Twitter Feed – Taking the number up to an even dozen now by my count, FDA opened a new Twitter feed called @FDAfood that allows you to follow the latest information on FSMA, food, nutrition, food additives and dietary supplements. The feed has been included on two of @eyeonfda twitter lists – the list of all FDA tweets and a list of twitter feeds on the subject of food safety.
- New Draft Guidance on Chronic Hep C Drug Development – FDA is announcing availability of a new draft guidance, which revises and replaces an earlier version, entitled “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment” to assist sponsors in the development of new treatments. The agency stated that significant changes exist in the new version.
- Goodbye CFC Inhalers – The completed phase-out of all inhalers medical products containing chlorofluorocarbons (CFCs) will occur by December 31 of this year, said FDA in a release this week. CFCs were used as a means to propel drug from an inhaler into the patient – and have been mostly replaced over time with a substitute propellant. FDA noted that while most inhaler products had already been phased out, there were two products still on the market – Combivent Inhalation Aerosol and Maxair Autohaler – which will no longer be available after the end of this year and the agency advised those using these products to talk to their health care professional about an alternative treatment.
I don’t know where the week went to. I had all sorts of plans for postings. But there is always next week. In the meantime, have a good, relaxing, safe and fun weekend.
