September 2014

29
Sep

FDA Warns of Lead in Product Targeted for Pediatric Patients

In another product safety alert, the FDA is warning patients, healthcare professionals and other caregivers not to use Eu Yan Sang (Hong-Kong) LTD’s “Bo Ying Compound” because tests have shown it contains high levels of lead. This announcement comes after a report of a case of lead poisoning in an 18-month old child given the product.

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23
Sep

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.

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17
Sep

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.

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16
Sep

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of Generic Drugs (OGD) posted its final Guidance on Refuse-to-Receive (RTR) Standards and also published an ancillary draft Guidance entitled ANDA Submissions – Refuse To Receive Standards for Lack of Proper Justification of Impurity Limits (which explains that proper justification for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).

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11
Sep

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.

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10
Sep

GPhA Annual Cost Savings Report Shows Larger Savings for the US Public

The Congressional Budget Office (CBO) report last month indicated that the cost of health care programs has slowed sharply. A large part of the savings is attributed to the cost savings realized through the use of generic drugs. This year’s GPhA Cost Savings report showed that consumers (including the US Government) saved $239 million alone in 2013 an increase of 14% over the savings seen in 2012. The 10 year savings from generic availability is reported at $1.5 trillion over the last 10 year period.

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08
Sep

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.

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