In a recent development, the US FDA has released a new guideline to assist the microneedling device manufacturers understand the product classification, applicable regulations, registration pathways and data requirements.
- November 30, 2020 Medical Devices, Regulatory Affairs
- November 23, 2020 Chemicals, Regulatory Affairs
Many countries are adopting, ban on animal testing, globally. Walking the same path, Brazil too has taken early steps towards the cause, but with many changes all through.
- November 23, 2020 Cosmetics Regulatory Services, Regulatory Affairs
Starting early 2020, due to the outbreak of COVID-19, it is observed that the demand and prices for soaps across the supply channels (at supermarkets, convenience stores, hyper markets, wholesalers, drugstores and pharmacies) have increased by a noticeable margin.
- November 19, 2020 Chemicals
Nowadays, cosmetic products have become a basic necessity for consumers across the world. Consumers, in turn, have their own set of concerns and limitations regarding what they want to use on their skin. And, it is needless to say that the industry is taking steps towards addressing these concerns and making it clear to use safe and effective cosmetic ingredients in their products.
- November 19, 2020 Medical Devices
Medical devices are evolving and embracing the technologies, so are the Regulatory pathways to govern them. To add to the same, the Brazilian national Health Authority – ANVISA, has published a guidance dedicated to the software with the intended medical purpose (Software as Medical Device – SaMD).
- November 19, 2020 Chemicals, Regulatory Affairs
It is well known that the risk of a chemical, majorly depends on the inherent toxicity of the chemical and the extent of exposure. In chemical management, determining the toxicity of chemicals is necessary to understand its potential to cause adverse effects when an organism, population or system is exposed to that specific chemical/agent.
- November 19, 2020 Compliance, Audit and Validation, Regulatory Affairs
The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future development of the FDA rating system.…
- November 19, 2020 Medical Devices
Brazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação).
- November 18, 2020 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format.
- November 18, 2020 Compliance, Audit and Validation
It is well known that COVID-19 has pushed many organizations to drive their auditors and the compliance teams adopt the right technology to perform remote audits. While remote audit techniques are similar to those of traditional audits, they leverage electronic means to obtain audit evidence for evaluations. The way or the procedure for remote audits depends on the business function and the operational procedures.