I am saddened to report that on Saturday January 4, 2020 my (our) good friend Don Hare passed away peacefully after a brief illness. When I heard the news, my heart broke. For those of us in the FDA or in the drug industry, he stood as a man among men and will be sorely missed by all that knew him.
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,
In a prepublication of the Federal Register today, the FDA announced its intentions to withdraw four NDAs (see chart below) for failure to submit required annual reports. In the notice, the Agency noted the firms have been contacted by the Agency but have repeatedly failed to submit the required reports. The Notice provides the firms with the opportunity to request a hearing prior to the Agency taking action to withdraw.
There have been eighty-six first-time generic approvals for the calendar year 2019 thus far, at least through November 8, 2019, according to the updated list by the FDA (here). The FDA wants us to remember that first approvals do not always translate into products that are immediately available to the public due to either patent issues,
Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem. Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy. There has even been one firm created expressly to aid hospitals to avoid or resolve drug shortages.
A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989. There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs,
In thinking about the current vaping issues, which have been associated with a significant number of deaths and hundreds, if not thousands, of lung-related injuries, I think the path to the future of these products needs to be critically evaluated by the FDA. The introduction of e-cig came so fast that the FDA was not prepared to deal with the issue.
CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here). The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise. The FDA says, “the changes increase the number of OND offices that oversee our review divisions from six to eight—and increases the number of OND clinical divisions from our current 19 divisions to 27,
Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]). The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints.
I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here).
This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014. The guidance document revision is based on comments that were submitted to the Agency after the original draft was introduced in 2018.
OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here). However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative approvals (13).
Oh, the games that are played to keep market share are becoming more curious every day. Just check out this article from Drug Topics penned by Louis Tharp and Craig Burton entitled Generics and Biosimilars Facing Formulary Difficulties (here). When Hatch-Waxman was passed, there were attacks on the bioequivalence of generic drugs,
In a seven-page response, the FDA denied an April 10, 2019 petition asking the Agency to place a moratorium on the approval of any new opioid products. The petition by Public Citizen spoke of the public health opioid crisis and asked that the moratorium be continued “until FDA has implemented recommendations from the National Academies of Sciences,
