Data Integrity Guidance Issues – Sounds Like a Softer FDA Song

While the number of data integrity (DI) findings have increased over the last few years, as evidenced by citations in a number of Warning Letters, the FDA stance on DI seems to have mellowed since the generic drug scandal of the late 1980s.  The FDA guidance document (here)   walks firms through their responsibilities in assuring that cGMP requirements relative to assurance of the accuracy,

Bioequivalence Study Recommendations Published for 35 Products

In an ever-increasing effort, the Office of Generic Drugs (OGD) is keeping on top of this aspect of industry’s desire to obtain guidance on establishing bioequivalence for generic drug products. Today FDA published new bioequivalence (BE) guidance for 35 drug products and revised guidance for 8 previously issued recommendations.  The entire listing of the newly issued and revised guidance document can be seen here.

Do the FDA Commissioner’s Remarks Spell Trouble for Generic Opioids?

In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them.  He emphasized that there needs to be a multipronged approach that reaches practitioners,

ANDA Approval Numbers for March 2016 Are In!

FDA had the second highest monthly post-GDUFA number of full ANDA approvals at 63, and with 16 tentative approvals the total for approval actions for March 2016 hits 79.

The full ANDA approval picture is looking a bit rosier with the second highest month this FY and also the second highest number of full approvals post-GDUFA.

TEA Anyone?

The FDA has published a proposed rule regarding Time and Extent Applications (TEAs) that will establish timelines and metrics associated with their review.  Just to remind you, a TEA is now the preferred option to add a product to an over-the-counter (OTC) monograph for products that were initially marketed in the United States after the OTC review began in 1972 and for products with no US marketed experience.

Do You Notice Something Missing? What the Heck!

About a week ago I began getting calls and getting feedback about a change in the Office of Generic Drugs (OGD) Approval letter format. What might appear at first to be a minor change has raised the eyebrows of many in industry and represents yet another “transparency” faux pas that occurred without warning or without explanation.

Generics Draft Abuse-Deterrent Guidance Issues

The questions about what and how a generic abuse-deterrent product has become somewhat more clear with the issuance today of the Draft Guidance for Industry – General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The Guidance document describes the types of tests (comparative in vitro studies and, in some cases, relevant pharmacokinetic or other studies that may be appropriate) that a generic applicant should undertake when seeking approval for a Reference Listed Drug (RLD) opioid product that has abuse-deterrent properties described in its labeling.

Who Are These Guys?  OGD Updates Part of Its Organizational Chart

The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.

Complete Response Letters Reach 3rd Highest Monthly Total Under GDUFA

February saw the 3rd largest number of Complete Response Letters (CRLS) issued (129) in a single month since the implementation of GDUFA. Previous highs were 134 in July FY 2015 and 130 reached in November FY 2013. With the review machine gearing up, wouldn’t one expect the number of CRLs to be steadily increasing each month? Maybe not! If the information requests (IRs) keep flying out the door along with easily correctable deficiencies (ECDs), then maybe the number of CRLs will remain lower. Or is that wishful thinking? That logic would seem to mean that the number of approvals should be soaring. Well, if you look at the total number of approval actions plus the number of CRLs, the total has actually been going up, and why? Because the number of monthly approvals has increased in FY 2016!

Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet?

The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Response Letters (CRLs) rather than clear movement towards application approval. Well, some three years into GDUFA I, there now seems to be a better understanding of what industry thought they got and FDA has adopted, albeit outside of the direct language in the Goals Letter, policies that are driving application towards approval.

MaPP 5240.3 on Prioritization of Original ANDAs, Amendments, and Supplements Gets a Facelift

Life is always a picnic and deciding what to bring is sometimes a chore. The key is to assure there are no ants! Well, the generic industry has waited to hear what would be brought to the prioritization picnic and now the third revision of the MaPP 5240.3 lays out the meal. The entire MaPP should be reviewed and studied carefully so you best understand the FDA position on priority and expedited review.

Another Sterile Compounder Under Fire from FDA

FDA issued an alert today telling healthcare professionals and patients not to use human and animal sterile drug product produced by a firm in Austin, Texas. After FDA inspection of the facility which found many objectionable conditions, the Agency recommended that the firm recall its products and cease production until the problems identified were corrected.