In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations. While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active at the time of this writing.
OGD reported the official approval actions, receipts, and Complete Response Letters for the first month of FY 2020. There were 57 full approval actions and 8 tentative approval actions for a total of 65 approval actions for the month of October (we reported 52 and 9 actions respectively here), so it appears that there were some adjustments made to arrive at the final official numbers (along with some delay in reporting full approval actions).
With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs. Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month for approvals.
In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals.
Unlike the statute and regulations for human drugs, there are no provisions for compounding animal drugs using bulk drug substances.
In a prepublication of the Federal Register today, the FDA announced its intentions to withdraw four NDAs (see chart below) for failure to submit required annual reports. In the notice, the Agency noted the firms have been contacted by the Agency but have repeatedly failed to submit the required reports. The Notice provides the firms with the opportunity to request a hearing prior to the Agency taking action to withdraw.
There have been eighty-six first-time generic approvals for the calendar year 2019 thus far, at least through November 8, 2019, according to the updated list by the FDA (here). The FDA wants us to remember that first approvals do not always translate into products that are immediately available to the public due to either patent issues,
(Westbury, NY – November 2019) Spanning approximately 120 minutes, part of the executive team from Lachman Consultant Services, Inc. (“Lachman Consultants”) guided 45 young professional engineers and chemists through an introduction to current Good Manufacturing Practices (“cGMP”) during ISPE’s 2019 Annual Meeting. As a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide,
On Wednesday afternoon at AAM’s GRx+Biosimilars Conference in Bethesda, MD, the FDA held a valuable workshop on Complex Generic Drug Products. The workshop opened with a general session explaining the opportunities for interacting with the FDA to get guidance and input while developing your complex generic and preparing your ANDA and how to get the most out of these interactions.
On the last day of at the Association for Accessible Medicines GRx-Biosims conference in Bethesda, members of the FDA joined industry for an informative and interactive discussion on post-approval supplements. Dr. Paul Schwartz and his colleague Olugbenga Okubadejo expressed satisfaction with the current state of the post-approval supplement process, as well as the example of teamwork it has taken to get it there (both within the FDA and also in partnership with industry).
Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner. Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues:
- Gaming the system through REMS and restricted distribution systems and patent issues
- Devising a path forward for faster approval of complex generic drug products
- Anticompetitive tactics
He also spoke about what,
Is there a Pre-Approval Inspection (PAI)? When will it be? Will our site be inspected? The anxiety-tinged queries from production (and management) personnel start almost as soon as an application is submitted, and until now regulatory personnel had little answers to offer except vague reassurances like, “We have to wait and see” or “It’s up to OPQ”.
At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, members of the FDA and industry came together to present opinions and discuss the Controlled Correspondence process. Controlled Correspondence (CC) between the FDA and industry is very much like an important pen pal relationship (where you only write to each other regularly, but never meet).
On the second day of AAM’s GRx-Biosims Conference, in Bethesda, Maryland, a session was held related to drug/device combination products. The session included several presenters from the FDA and industry. While the challenges with the drug/device combinations was well covered in the session, there wasn’t a lot of focus on the opportunities.
The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success. This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products.
On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) spoke on The Importance of Global Regulatory Harmonization for Biosimilars.
An interesting session during the GRx+Biosims conference held in Bethesda on November 4, 2019 addressed Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process. The presentations from the FDA, as well as industry, acknowledged that the adequacy of drug master files (DMFs) for APIs in one cycle has been a lot more challenging compared to that of the first-cycle approval of ANDAs.