Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics. We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]
June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions). With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions. This total of […]
The “rain” of approval actions in April led to an unofficial “sprouting” of 83 full approvals in May, which was the largest number of full approvals seen in quite some time; specifically, since May 2019 when there were also 83 full approvals. While not an all-time high for a single month, it is a welcome […]
Yesterday, the Office of Generic Drugs released twenty-four new and thirteen revised Product Specific Guidances (PSGs) with recommendations for conducting studies necessary to establish bioequivalence between test and reference products. Of course, the revisions might spell trouble for applicants that have already commenced testing according to the original guidances, but this has been a bone […]
When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]
Tuesday’s session of the Fiscal Year (FY) 2022 Generic Drug Science and Research Initiatives Public Workshop opened with a presentation by Michael Banks, Senior Vice President, Global Head Regulatory Affairs, Teva Pharmaceuticals discussing the global challenges to the development of complex generic drugs. Dr. Banks challenged the regulatory bodies to move towards more standardized approaches […]
As our world spins toward the highly anticipated “new normal,” pharma and related industry conferences in the last few months have shown us that the new normal will be anything but business as usual. Instead, we are witnessing an accelerated adoption of advanced new technologies that many of us had previously associated with the IT […]
In today’s SBIA Generic Drug Forum, there were a number of presentations related to generic drug statistical reporting. As someone who tracks OGD activities somewhat obsessively, these presentations validated many of the observations that I’ve been making in my blog posts on the OGD’s public statistical reporting. The presenters reviewed the types of required and […]
Used for years as an “unapproved” drug for lightening of skin color, the FDA issued warning letters to twelve firms selling the drug, telling them that hydroquinone is not generally recognized as safe and effective. On August 29, 2006, the FDA issued a Notice of Proposed Rulemaking that would establish that over-the-counter (OTC) skin-bleaching drug […]
On April 15, 2022, FDA published a Manual of Policy and Procedures (MaPP) that outlines the FDA thinking on what constitutes a complex drug product for purposes of classification. A MaPP, as you know, is not an industry tool, but rather an instruction to FDA staff as to the policy and procedure that they utilize […]
