Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products

With the FDA’s move to reduce the amount of acetaminophen (APAP) for prescription combination products to no more than 325mg per dosage unit completed, FDA seems to be moving into the Over-the-Counter (OTC) arena to help reduce potential overdose or medication errors with liquid APAP products targeted for pediatric patients. Today, FDA released the draft Guidance Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

Rare Pediatric Disease Priority Voucher – What Will You Pay for Speed?

Today, the FDA announced the 2015 fee for the use of a Rare Pediatric Disease Voucher in a Federal Register (FR) notice (here). Created by the FDA Safety and Innovation Act (FDASIA), this program provides a voucher to a sponsor that gains approval for an NDA for a product used to treat an indication that has been classified as a rare pediatric disease. There is a price for use of the voucher and it ain’t cheap-the voucher fee for 2015 is fixed at $2,562,000.

Rare Pediatric Disease Priority Voucher – What Will You Pay for Speed?

Today, the FDA announced the 2015 fee for the use of a Rare Pediatric Disease Voucher in a Federal Register (FR) notice (here). Created by the FDA Safety and Innovation Act (FDASIA), this program provides a voucher to a sponsor that gains approval for an NDA for a product used to treat an indication that has been classified as a rare pediatric disease. There is a price for use of the voucher and it ain’t cheap-the voucher fee for 2015 is fixed at $2,562,000.

PQRI Presentation Provides Interesting Insights

In a September 17, 2014 presentation at the FDA/PQRI Conference on Evolving Product Quality given by Susan Rosencrance, Ph.D., Acting Deputy Director, Generic Drug Chemistry in the Office of Pharmaceutical Science at CDER, a number of interesting issues were presented and discussed. Some of these issues may be a welcome sign to the industry of a turnaround at OGD, but others still need some explaining.

GDUFA Policy Hearing – Where is the Silver in this Lining?

On September 17, 2014, FDA hosted the GDUFA Public Hearing on Policy Development. With quite a few generic firms of all sizes represented at the hearing, a series of recurring themes appeared to resound. Lack of communication and transparency from FDA and ever growing facility fees that stifle entry of small new players were the loudest complaints from the audience.

ANDA RTR Guidance Finalized with Some Important Changes – Issuance on Draft on Impurity RTR

n September 16, 2014, the Office of Generic Drugs (OGD) posted its final Guidance on Refuse-to-Receive (RTR) Standards and also published an ancillary draft Guidance entitled ANDA Submissions – Refuse To Receive Standards for Lack of Proper Justification of Impurity Limits (which explains that proper justification for specified identified impurities above qualification thresholds and specified unidentified impurities and unspecified [unknown] impurities with limits above identification thresholds must be included in the ANDA or it will receive an RTR letter).

Approvals Bounce Back at OGD in August; ANDA Submissions for the Month at a Tie for All Time Low

As FY 2014 draws to a close, the Office of Generic Drugs (OGD) has approved 45 ANDAs in August, the highest number for any month in this fiscal year, and through August 31 OGD has approved a total of 361 ANDAS thus far for this FY. In a repeat performance from last month, OGD reported receiving only 4 original ANDAs. Looks like firms are waiting for the October 1 to submit their ANDAs as the GDUFA metrics begin being applied to the cohort year 3 submissions.

Responsiveness to Emergency Access INDs

Ever since I began my career at FDA in 1985 and straight through until today, I have heard the Agency criticized for failing to respond to patients needs regarding to access to new life saving treatments. There are new initiatives being discussed relative to patient’s ability to access new and unapproved treatments for serious, life threatening conditions, but the same arguments of ethics still hang visibly on each side of the issue. Over the weekend, I stumbled across something I had not seen before on the CDER web page; it was a link to the Expanded Access Submission Receipts Report.

NMEs for 2013 – Some Interesting Facts

While the number of new molecular entities (NME) filed in 2013 (a subset of all NDAs filed) was lower than in 2012 (36 vs 41), there are some interesting facts associated with how CDER did on approvals. For instance, of the 36 NMEs filed in 2013, FDA approved 27. This compares with 39 of the 41 submitted in 2013.

Follow-up on Visible Particulate Matter in Parenteral Products

In a blog post on August 12, 2014, I raised the question of why there have been so many recalls of parenteral products related to visible particulate matter. There are a multitude of factors that lead to the formation of particulate matter, some of which have to do with formulation, some with storage, some with handling, some with manufacturing equipment and the like as was discussed in the blog referenced above.