Regulatory Strategy and FDA Policy

The development of drugs, biologics, and medical devices follows rigorous paths to ensure safe and effective medicines. We create FDA regulatory engagement strategies and help clients interpret FDA regulations, guidance, and the likely impact of legislation. Interpreting FDA priorities, resources, User Fee Acts, and label and promotion requirements, our experts can help you manage your pipeline.

Three Ways the FDA Can Facilitate Claims of Interchangeability

In the US, an interchangeability designation by the Food & Drug Administration (FDA) is perceived as the holy grail in biosimilars development by some and yet regarded as irrelevant by others.

FDARA Builds on Progress in Expanded Access

The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, calls on FDA to examine underlying barriers to access to investigational drugs.

Interview: E2 – Highlights of FDA and NIH in 21st Century Cures

The final signing of the 21st Century Cures Act is the culmination of 3 years of efforts by lawmakers in the House and Senate to expedite developing and making available new treatment options. In the final episode in our series, Jay Jackson discusses what changes are on the horizon for products under The Cures Act.

FDA Has Received $7.67 Billion from Manufactures to Fund Drug Review

Since 1992, the Food and Drug Administration (FDA) has collected $7.67 billion in user fees from pharmaceutical manufacturers to fund drug reviews based on an Avalere analysis of FDA data.

Commercial Uncertainty Remains as US Biosimilar Pipeline Matures

With the recent announcement of the U.S. Food and Drug Administration's (FDA) acceptance of a submission for approval of a second biosimilar to Remicade (infliximab), questions remain for biologics manufacturers, payers, prescribers, and others as to how a mature biosimilars pipeline will begin to evolve in the United States and whether a sustainable competitive specialty market will develop.

Interview: FDA Efforts in Patient Engagement

In recent years, stakeholders have increasingly become aware of the potential opportunities surrounding incorporation of the patient perspective into early stages of drug development. Listen to Debleena Sengupta discuss how patient input is evaluated and incorporated into the FDA's decision-making process.

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