In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget’s Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.
The buzz about abuse-deterrent opioids (no pun intended) in some camps seems to view these products as a panacea for the prescription drug abuse problem. In my view, that is far from the reality of the problem and clearly miles from the solution.
In response to stakeholder requests, the FDA has delayed the enforcement date only for dispensers under the Drug Supply Chain Security Act (DSCSA) until November 1, 2015.
The FDA has posted a Drug Safety Podcast on its website (here) that describes an adverse drug event (ADE) associated with use of a drug indicated to treat attention deficit hyperactivity disorder (ADHD).
After reading a nice blog post by Kurt Karst and Josephine Torrente on the FDA Law Blog (here) on a push to release Complete Response Letters (CRL), I thought to myself (at first),
The FDA is looking for a few (or a lot) more good employees and is holding another virtual hiring event. Could FDA be looking to obligate a portion of the $277 million excess of GDUFA funds that have not yet been spent from the fees collected in the first 2.5 years of the program?
Not surprisingly, the FDA said they were doing the best that they could with a new program, and industry said, so far, not good enough. While these may seem like diametrically opposed views, my understanding is that the apparent positions are not as far apart as they might appear.
While I rarely use others’ comments in full to populate this blog, I think that Ralph Neas, President and CEO of GPhA, said all that needs to be said on the state of GDUFA and the hope for future improvements – so here is.
On March 26, 2015, we blogged about an April 20-21 FDA Public Hearing regarding examining the need for the drug enforcement policy surrounding homeopathic drugs. Since the conclusion of that hearing, just under 3500 comments have been received from FDA.
Today is June 11, 2015, and there are major milestones being hit. First of all, today is my 44th wedding anniversary – that’s a big one! But also, by the end of the day, the Office of Generic Drugs (OGD) will have close to 30
Just a quick note about yesterday’s posted figures, OGD updated the figures as follows:
In a Federal Register notice today (here), FDA announced its finding that Ondansetron Hydrochloride Injection USP, in plastic, ready-to-use containers containing 32mg/50mL was removed from the market and withdrawn for safety reasons.
In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.
The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month…..
The Office of Generic Drugs (OGD) had another good (OK) month in terms of approval actions with the approval of 44 ANDAs and tentative approval of 13 for a total of 57 approval actions for the month. The number of receipts totaled 40 – obviously just under the number of full approvals for the month.