Newsletter | February 23, 2024

02.23.24 -- Getting Generic Drugs Right: FDA Revises ANDA Guidance

FEATURED EDITORIAL

Getting Generic Drugs Right: FDA Revises ANDA Guidance

By Tim Sandle, Ph.D.

To improve the quality of abbreviated new drug applications (ANDAs) and to ensure improved consistency, the FDA has developed a new guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval. This new guidance replaces the previous September 2020 version.

INDUSTRY INSIGHTS

Knowing When To Take Action In A Regulatory Submission Crisis

Article | By Jenny Minigh, inSeption Group

While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these can be avoided.

Wet Milling Vs. Dry Milling In The Pharmaceutical Industry

Article | Ascendia Pharma

Read about the necessary considerations for choosing between wet milling and dry milling for a specific active pharmaceutical ingredient.

Rapid, Material-Sparing Feasibility Screening For Hot Melt Extrusion

Webinar | Lonza

Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time.

Empowering A New Era Of Patient-Centric Medicines

Podcast | Nanoform

Understand the challenges companies are facing as they switch focus, along with the actions and technologies they are implementing to achieve a brighter future for patients.

Outsourced Drug Development: Short-Term Solution Or Long-Term Strategy?

Webinar | Cambrex

A panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

Ready To Help Meet Your Complex OSD Needs, Seamlessly And Simply

Article | Pfizer CentreOne

Learn how to identify a reliable CDMO partner with services suited for your project’s needs and the capability to help you efficiently navigate the path to market.

SOLUTIONS

Real-World Dosing Solutions For Patients

Catalent

Orally disintegrating tablets enhance pharmacokinetics and improve compliance. Zydis® fast dissolve can enhance your investment and increase your product’s potential.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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