Formulation and Drug Delivery

Biologics and Compounding Rules Change

March 05, 2020

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

FDA Provides Answers to Biologics License Questions

March 05, 2020

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

Keeping Toxicity to a Minimum

March 02, 2020

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

Going with the Flow

March 02, 2020

Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.

By Popular Demand: The Growth of Biopharma Outsourcing

March 02, 2020

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

Fast vs. Formulated?

March 02, 2020

Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?

Characterizing APIs is Essential for Combo Drug Formulations

March 02, 2020

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

Catalent and Perrigo Announce Approval of Generic Version of Teva Inhaler Med

February 27, 2020

Perrigo will be producing a limited amount of the generic inhaler medication but will accelerate production to meet future demands in collaboration with Catalent.

Researchers Discover Way of Continuously and Precisely Dosing Active Agents

February 21, 2020

Researchers at the Technical University of Munich (TUM) have discovered a way of continuously and precisely dosing active agents using an oil-hydrogel mixture.

FDA Smooths Transition of Biologic Approvals

February 21, 2020

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.