Another 70 Month for ANDA Approval Actions

The Office of Generic Drugs (OGD) is starting off FY 2016 at the same level that they ended FY 2015, with a total of 70 approval actions, one less than September’s record total.  The breakdown is- 49 full approvals and 21 tentative approvals (TA).

While I am certain that industry would like to see more full approvals,

How Deep is FDA Diving in GMP Compliance for Compounding Pharmacies? Just Watch the Recalls and Warning Letters!

With Warning Letters (WLs) and significant FDA 483 observations continuing to confront the compounding pharmacy space, FDA is entering into rounds two and three of inspections to determine if corrective actions have been adequately and timely completed and if the compounding pharmacies understand compliance in this space

Six Degrees of Shortage Prevention: ISPE Debuts New Gap Analysis Tool

Serving as a member of the pharmaceutical industry is a privilege that brings with it significant personal responsibility. In recent years, preventing and mitigating drug shortages has become a critical concern for every pharmaceutical professional. ISPE is leading an international effort to understand, assess, and educate patients, providers, regulators, and manufacturers on this critical topic.

To Compound or Not to Compound? That is the Question!

To Compound or Not to Compound? That is the Question!

FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use in the compounding of drug products and has described its interim enforcement policy regarding drugs compounded under Section 505 A (dealing with pharmacy compounding) and Section 503 B (dealing with outsourcing facilities) of the Federal Food Drug and Cosmetic Act.

Single Patient Use – A New Label Term for Parenteral Products

FDA published a new draft Guidance entitled, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”. This draft Guidance adds to the two specific terms that FDA has long use for parenteral products – single-dose container and multiple-dose container- but they have even tweaked those terms

The Ying and Yang – CRLs vs IRs ECDs and Approvals

Complete Response Letters (CRLs) (remember those letters where FDA was going to respond all at once with Division level review and you were not going to get any more discipline specific letters?) are a harbinger of “approval issues that are too great to resolve through other means”. Yes, that’s right, expect a CRL if issues are complex or too vexing to permit approval.

No More FPL Required for ANDA Approval

In a Federal Register (FR) Notice today (here) , FDA has indicated that a long-held practice of requiring the submission of actual or printers proof of final printed labeling (FPL) will no longer be required for ANDA approval, and that OGD will accept draft labeling for approval purposes.