FDA Improves Transparency and Predictability for Generic Drug Applicants
The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.
FDA announced on June 18, 2019 that it was adding data points to its Paragraph IV Patent Certifications List to better inform generic-drug applicants about the potential for their products to be able to be approved and marketed. This change comes as part of the agency’s effort to promote generic-drug options for patients.
The Paragraph IV Patent Certifications List provides information about exclusivity as it relates to generic-drug challenges of patents on brand drugs. Generic-drug applicants can apply for FDA approval of a generic drug before a patent expires on the brand drug if they assert the patent is invalid, unenforceable, or will not be infringed by the generic drug. This assertion comes in the form of a statement called a Paragraph IV certification, as part of an abbreviated new drug application (ANDA).
FDA has added additional data points to the list, including the status of 180-day exclusivity decisions, dates of first approval, marketing status, and expiration dates of blocking patents. The number of applicants that are potentially eligible for 180-day exclusivity will also be shared, allowing generic-drug manufacturers to determine whether or not to develop a generic version of the drug.
“With the update today, this new data may allow generic applicants to make more informed business decisions about which of their specific generic drug applications have a higher likelihood of being approved sooner. This data may also provide more public transparency into instances in which the FDA approves an ANDA with exclusivity, but the generic product is not marketed for an extended time which among other reasons may signal ‘gaming’ tactics in the generic market,” FDA stated in a press release.
Source: FDA
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
