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Ranbaxy Lawsuit Denied

A lawsuit from Ranbaxy against the FDA to reinstate approvals that were revoked based on FDA’s findings of data integrity breeches (IPQ April 28 2014 pp. 19-29) was thrown out by a federal judge in late February. In revoking them, FDA denied Ranbaxy the six month exclusivity it would have received for being “first-to-file” generics.

EMA to Share Generics Assessments

EMA announced in mid-January that it would share its assessments of applications for generic drugs with other regulatory agencies. The first phase of its “International Generic Drug Regulators Pilot,” started in July 2014, involves the EU, Australia, Canada, Chinese Taipei, and Switzerland. Initially ten applications for generics will be shared.

Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication

FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID)....

FDA Criteria for “First Generic” ANDA

In the Federal Register in mid-November, FDA proposed a common definition for “first generic” in order to clarify the agency’s prioritization of ANDA approvals. A MAPP from August 2014 stated that the review of ANDAs that are “first to file” would receive prioritization, but did not provide a distinct definition. The Federal Register states that […]

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....

Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally

The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies. Comments on the drafts are due by mid-September....

IPQ Monthly Update, June 2014

In focus are: ● FDA’s new process for risk-ranking ANDAs ● an update on other FDA efforts under GDUFA to clarify and streamline its generic drug review process ● the pressure coming from industry to establish an independent review process for new and modified excipients ● advice from FDA compliance experts on proactive GMP communications, and ● the compelling results of Amgen’s eight-year effort to upgrade its nonconformance investigations and follow-up processes to find and address root causes....

FDA Releases Draft Guidance on ANDA Content and Format as Efforts Continue to Clarify and Streamline Review Process Under GDUFA

A draft guidance on the content and format of abbreviated new drug applications (ANDAs) is the most recent effort by the Office of Generic Drugs (OGD) to clarify and streamline the ANDA process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA). The draft was released in mid-June for a 60-day comment period....

FDA Deploys Risk Ranking Process to Streamline ANDA Review

FDA’s generics office has developed a risk assessment algorithm for the review of abbreviated new drug applications (ANDAs) to help address the challenges of balancing more extensive quality-by-design-based submissions with the foreshortened review timelines mandated under the Generic Drug User Fee Act (GDUFA)....
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