Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.
- July 30, 2018 Regulatory Labeling
- June 19, 2018 Publishing & Submissions
Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region.
- June 1, 2018 Medical Devices
On April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.
- April 26, 2018 Regulatory Labeling
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.
- April 18, 2018 Regulatory Affairs, Publishing & Submissions
An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and Research (CDER) has the authorization to designate IND as commercial if it finds the intent to commercialize the drug in future. In the United States, INDs must be registered with the Food and Drug Administration (FDA).
- March 15, 2018 Regulatory Medical Writing
Finished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They can be residual catalysts from synthesis or might get picked when in contact with manufacturing equipment, containers or other sources.
- March 14, 2018 Regulatory Artwork Services, Regulatory Labeling
Effective communication can bridge information gaps between two different ends of a process. With so many processes involved and with a need to communicate accurate safety information to the end user, the Pharmaceutical industry must employ utmost caution when taking its products to market.
- March 13, 2018 Medical Devices
In Europe, the demand for medical devices has increased by many folds. While medical device manufacturers are relying on the market demand, they must also make sure how their product is considered and classified in Europe. The fact that the device is accepted in other countries like USA, Canada or Japan does not always have to be conformed to the European Device Directive (EDD).
- March 12, 2018 Publishing & Submissions
We are all aware, that the United States Food and Drug Administration (USFDA) has extended compliance date for Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format, i.e., 5th May 2018.
- February 21, 2018 Regulatory Labeling
Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The commencement date of the new PI form was 1st January 2018, with a transition period of three years ending 31st December 2020.