Is a mature pharmaceutical quality system really a competitive advantage? The industry held this as a belief, but progress in a tangible program was always elusive. On November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]
GDUFA III Raises Hopes for Surprise PSG Issuance/Revision Explained at AAM’s GRx-Biosims Conference The product specific guidance (PSG) has been a big help to industry in outlining the requirements for establishing bioequivalence requirements for generic drug products. OGD has issued over 2000 PSGs since the practice began. While this has been a big boon to […]
This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready. […]
I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators. Although I found all of the […]
At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]
Today the FDA issued a guidance entitled Cross Labeling Oncology Drugs in Combination Regimens (https://www.fda.gov/media/162806/download) that describes the Agency thinking on cross labeling of oncology drugs for which there is a proven benefit from their combined use. As I read the guidance a few things popped into my mind. How can one firm who owns […]
For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers […]
The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices conference was held in Palm Springs, CA, October 18-19, 2022. In attendance were some of the world’s largest providers in this combination space which included innovators, pharmaceutical companies, suppliers of injectable devices and contracted service providers. The conference speakers presented on a variety of topics […]
Well, with the final FY 2022 totals now in for some of the OGD’s most important metrics, let’s see how this fiscal year stacks up other GDUFA years. But first, September saw sixty-eight full-approval actions of which nine were for first-time generics and only nine tentative-approval actions along with ninety-eight new ANDAs and 141 Complete […]
As former OGD Director Kathleen “Cook” Uhl, MD used to say, “Read the commitment letter.” This certainly applies for GDUFA III and in spades. Why? Because a number of enhancements that were made in the GDUFA III negotiations are designed to make the review process more efficient and improve the number of first‑cycle approvals. In GDFUA I and […]
