Stakeholders Ask FDA to Harmonize Guidelines for Oligonucleotide-Based Therapies
The biopharmaceutical industry and other stakeholders are pressuring the US Food and Drug Administration (FDA) to harmonize its regulatory guidelines for oligonucleotide-based therapies. The request aims to eliminate discrepancies in the development, manufacturing and approval requirements for these innovative treatments, which have shown great potential in the fight against various genetic and infectious diseases.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.
FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development
The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.
FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review
In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.
Transfer certificate of GMP and Ownership of Products: What Companies Need to Know
The transfer of Good Manufacturing Practice Certificates (GMP) at Anvisa is a specific process, usually related to changes in certificate ownership due to corporate reorganization, such as mergers or acquisitions.
QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force
The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
US-FDA Publishes New Requirements for OTC Drugs Labeling
On September 8,2022, FDA published the draft of a guideline that provides recommendations on the labeling of OTC drugs.
FDA publishes product-specific guidances to facilitate generic drug development
FDA publishes product-specific guidance’s to facilitate generic drug development.
Registration of Generic Drug Registration (ANDA) with the US FDA
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.