FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval
The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).
FDA Adding Common Ingredient to the Major Food Allergen List Starting
On January of 2023, the U.S. FDA added sesame to the official list of major food allergens, as identified by the Food Allergen Labeling and Consumer Protection Act of 2004, that includes milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans.
Japan’s PMDA Remote Inspections
The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
The UK’s MHRA provides more provisions on Pharmacovigilance
UK MHRA publishes UK, (12A) to Regulation 205A, providing provisions for pharmacovigilance activities and PMSF requirements.
FDA Updates Medical Device Establishments Inspection Processes and Standards
FDA released a final guidance on inspections of medical device establishments requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
How to make Hand-Sanitizer: WHO and FDA recommendations
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Regulatory Challenges faced by Cosmetic Companies
Cosmetics is a dynamic industry, with new novel products ready to market it puts significant pressure on companies to understand global regulation and registration processes in order to reach consumers and markets globally.