Remove Marketing Remove Packaging Remove Regulations
article thumbnail

Article EMA: What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

article thumbnail

Experiencing the CBER: Anticipating Unique Challenges

Cytel

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the two main divisions of the FDA responsible for regulating drugs and biological products, as well as combinations of drugs and biological products.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Zebrafish Value Proposition for Cosmetic Testing

biobide

Background on the Cosmetics industry In 2022, the value of the global cosmetics market was estimated to be worth USD 262.21 Additional contributing factors include an increased awareness of fashion trends, innovations in the areas of hair coloring and skincare product formulations, and developments in the area of packaging.

article thumbnail

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law Blog: Biosimilars

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

article thumbnail

PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). PMA or 510(k)) is required.

FDA 98
article thumbnail

Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog: Biosimilars

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

article thumbnail

Article Periodic Thank You What we expect EU chemical regulators to do in May 2024

Agency IQ

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.