ARTICLES BY ESTEL GRACE MASANGKAY

• UK Regulators Introduce Online Registry For Low-Risk Medical Devices

  2/10/2015

  On February 11, 2015, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) will launch the Devices Online Registration System (DORS), a web-based registry for low-risk, Class 1 medical devices.

• FDA Commissioner Hamburg To Resign In March

  2/6/2015

  U.S. Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg has announced her plan to resign at the end of March 2015. She has held the post for nearly six years and is one of the longest-serving FDA commissioners in recent history.

• FDA Releases cGMP Draft Guidance For Combination Products

  1/30/2015

  The U.S. Food and Drug Administration recently issued draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products. The draft guidance intends to clarify cGMP requirements for combination products and provides hypothetical scenarios illustrating compliance considerations for certain types of combination products.