Strike three

FDA Proposes to Withdraw Applications – Failure to Submit Annual Reports

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.

Rapid motion photo of horses at a race track finish line

Drug Shortages Report Provides Look Forward

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.

Draft DMF Guidance Issued by FDA

A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989.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,

Closeup of woman smoking electronic cigarette

E-Cigarettes – What Will Be Their Fate?

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. 

Human resources restructuring process illustrated on blackboard

CDER Office of New Drugs Reorganization and Impact on OPQ and Office of Translational Sciences Announced

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,

Athlete Jumping over Hurdles

Compounding vs. FDA Approved Product Presents a Conundrum Regarding the Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor

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. 

Woman on the phone looking confused at a broken computer

Don’t Panic – ANDA Approvals Continue To Roll Along – But A Glitch Might Not Make Them Immediately Visible

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).  

Petition Form

Revised 505(q) Petition Guidance Published

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. 

Question Marks on Blackboard

Silver Spring – We Have a Problem! August Approval Numbers Don’t Add Up!

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). 

Doctor holding a clipboard with Safety first, Medical concept

FDA Denies Public Citizen Petition Asking for a Moratorium on All New Opioid Approvals

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,

Glass 3d buttons. Up and down

One Week Left in August – How Do the Approval Numbers Look for Generics?

I don’t know about you but has this year flown by or what?  Summer will be over on Labor Day and there will be only one month left in FY 2019.  OGD approval actions thru reporting on August 22 show OGD with 53 full approval actions and 11 tentative approval actions.  Thus, it looks like OGD will beat the last two fairly slow months that had total approval actions of 62 (45 full and 17 tentative),

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.  The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.

As a reminder, the FDA has not regulated child-resistant packaging since 1973,