Ms Emily Marden

Emily Marden

Updates

Healthcare & Life Sciences

FDA's flurry of food and cosmetic activities continues unabated
USA | 01 February 2017

As the Obama administration drew to a close, the Food and Drug Administration's Centre for Food Safety and Applied Nutrition (CFSAN) continued to release multiple final or interim final rules and guidance documents pertaining to food safety, nutrition labelling and cosmetic safety. The CFSAN also began posting adverse event reports for foods and cosmetics and extended its comment period for 'healthy' claims in food labelling.

FDA's final medical foods guidance maintains restrictions on category
USA | 08 June 2016

The Food and Drug Administration recently finalised its August 2013 draft guidance entitled "Frequently Asked Questions About Medical Foods; Second Edition". Although the draft guidance was issued nearly three years ago and was the subject of numerous comments from stakeholders, the final guidance reflects few changes and ignores the legal and science-based comments from the industry.

FDA draft biologics guidance would rescind innovator exclusivities
USA | 13 April 2016

The Food and Drug Administration recently released a draft guidance regarding the implementation of the 'deemed to be a licence' provision of the Biologics Price Competition and Innovation Act. The guidance takes the surprising step of limiting innovator exclusivities as part of 'deeming' products to be licensed as biologics under Section 351 of the Public Health Service Act.