United Kingdom’s MHRA releases a list of exempted medical devices
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.
Steps to take if you have a COVID-19 confirmed positive worker: CDC Recommendations
The FDA encourages and outlines major steps to be taken as per the CDC recommendations to help prevent and slow the COVID-19 in the office.
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
US FDA releases COVID-19 vaccine guidance
The United States Food and Drug Administration (USFDA) recently released a guidance for COVID-19 vaccine demonstrating at least 50% effectiveness in a placebo-controlled trial.
Brazil’s Anvisa updates conduct of clinical trials with Technical Note 22/2020
Anvisa publishes a Technical Note 22/2020 updating the guidelines for sponsors, research centers and investigators involved in conducting clinical trials.
US FDA releases its first patient focused drug development (PFDD) guidance
The US FDA has released its first patient focused drug development (PFDD) guidance. This guidance is the first methodological guidance( referred as guidance 1) and that will be followed by 3 more guidance’s on this topic.
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.
US FDA Facilitates Intellectual Property Rights For Dietary Supplements
The US FDA proposes useful tools to register innovative dietary supplement for New Dietary Ingredient – Master file (NDI-MF).
China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies
Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers. New Drug Review […]
The Newly Enacted CARES Act reforms the FDA OTC Monograph Process
The United States Food and Drug Administration reforms the Over the Counter (OTC) process under the CARES Act signed by Congress in March ’20 to provide emergency relief affected by the COVID-19 pandemic.
Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19
The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
EMA waives GMP inspection fees during COVID-19
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.