Jump to navigation
On May 27, 2016, the United States Food and Drug Administration (US FDA) published the final rule for nutrition and supplement facts label in the Federal Register. The final rule ensures that the label reflects new scientific information including the link between diet and chronic diseases like obesity and heart disease.
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June 2015, establishes a labeling standard for prescription drug products which can be used during maternity and lactation.
Do you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.
Is it the clinical pharmacology section of generic drugs and biologic’s labels requiring your attention? Are you chalking out a plan to gather the related data? Then it is the time you should know about Food and Drug Administration’s (FDA’s) finalized guidance on labeling. Here’s a quick overview.
What is Clinical Pharmacology?
Now that we have decoded various Regulatory Labeling challenges from different perspectives, is it the time you think to scout for a comprehensive Regulatory Framework?
In an ever changing Regulatory environment, health authorities around the world mandate drug companies with various drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle.
The accelerated introduction of new regulations and guidelines for pharmaceutical labeling industry during past few decades, demands companies to be pro-active in terms of the implementation lifecycles. The dire consequences associated with the erroneous label on a drug or a medical device accounts to severe health risks for the patients.
Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance.
Artwork and labeling development in the pharma industry involves several groups across the organization, handling these processes but in most cases external service providers support companies to streamline the entire pharmaceutical labeling and artwork lifecycle.
Recently FDA has confirmed announcement of a major and final rule of labeling coming in July 2016 that will entail new guidelines for updating labels of generic drugs in terms of safety information. Announcing this final rule, FDA intends to make the process of label update easier for generic drug companies.
Influence of Present Rule
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
Get Blog Updates Delivered Straight to Your Inbox