On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.
FDA publishes product-specific guidance’s to facilitate generic drug development.
Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug.
THE US-FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain
FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
On May 2022, the FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product
On May 12, 2020 ANVISA published new resolution RDC Nº 383 that addresses the direct import of products by health centers.
In an effort to support sponsors responding to the public health emergency of COVID-19 pandemic, On May 2020, the FDA provided a guidance to assist sponsors in preparing pre-IND meeting requests for COVID-19 related drugs (human drugs and biological products).