Regulatory Filings and Submissions

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

Draft guidance from FDA includes information essential for the completion of ANDA applications.

Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer.

FDA clarifies stability data recommendations for abbreviated new drug applications.

High technology assessments are having an impact on biosimilars development in Europe.

FDA and EMA launch initiative to share bioequivalence inspection information.

OGD is under pressure to improve review operations.

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.

FDA publishes guidance on ANDA submissions.

Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

EMA streamlines orphan drug application procedure.

The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.

Additional approvals in December have helped to outpace a recent high set in 2011.

On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.

How niche strategies can offer mainstream potential for biopharmaceutical companies.

The contract provider needs to know as much as the NDA holder.

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.

Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy.