In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]
With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month. These numbers are derived from the FDA’s All Approvals page here. Compared […]
Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective. Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 […]
FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was […]
OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing. We missed the approval actions by one. OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of […]
Today, the FDA issued a draft guidance titled Using the Inactive Ingredient Database (here). The guidance describes how to use the inactive ingredient database (IID) and its limitations. FDA has been using the IID since 1987 and has committed to updates throughout the year that provide more current and useful information. Excipients are constantly being […]
On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions. The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015. The update is more of a finalization; the portion of the draft that sets forth the submission procedures for […]
New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs. It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act […]
Yesterday, FDA announced the eligibility of ANDAs submitted for drug products indicated for the emergency treatment of known or suspected opioid overdose, to be granted priority review status (either shorter goal dates, or expedited review without formal reduction of the goal date) under the public health emergency option stated in MAPP 5240.3 (priority criterion number […]
We reported here that June may be a gloomy month for approval actions. A few days ahead of the release of the official OGD numbers, it looks like we were on target. As reported through this morning on FDA All Approvals List (here), OGD had issued 44 full approval actions and 17 tentative approval for […]
