Regulatory Filings and Submissions

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.

The guidance provides examples of required and recommended information in the Dosage and Administration section.

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).

New medications show exciting outcomes for weight loss.

FDA keeps its user fees but fails to gain important reforms.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

CBER maps modernization plan to handle surge in research and applications.

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

The European Union publishes long-awaited changes to Annex 1.

Addition of a testing lab to an existing testing site as a Post Approval Change (PAC) is considered low risk when there is no change to testing procedure, specifications, equipment, and the additional lab is already approved by health authorities for other testing activities. Such PACs should be managed in the Pharmaceutical Quality System (PQS) only rather than requiring prior approval.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.