The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway.

Two members of the U.S. Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee resigned after the agency’s approved the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen/Eisai), against the committee’s recommendation. The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway. Price forContinue reading “The 11-member committee voted nearly unanimously in November that Biogen’s drug should not be approved. The FDA approved it anyway.”

Tracking you without consent

Reposted by permission from Liberty Counsel Action. A sloppy 60-page “study” just exposed chilling levels of contact tracing of nearly every single person in a target community, including those not sick. But after digging, our team found that this data is being gathered all across America into one daily hub cataloging every move you make. Even if you don’tContinue reading “Tracking you without consent”

Selling off your choice to vaccinate?

Reposted by permission from Liberty Counsel Action Is your decision to vaccinate, or not, being bought and sold? High-powered pharmaceutical lobbyists and career politicians are gathering around the table to decide what decisions they will leave up to you about impending COVID-19 vaccinations. Our freedom depends on making our voice heard, right now. Urge ourContinue reading “Selling off your choice to vaccinate?”

ICH is coming to Town – European Medicines Agency (EMA)

The International Conference on Harmonization (ICH)  is involved in promoting public health, improve efficiency of new drug development and registration process among other objectives. In order to accomplish this, ICH has developed and implemented harmonized guidelines and standards, also known as ICH6. Over 50 guidelines on technical requirements on: Quality, Safety and Efficacy • Efficacy –Continue reading “ICH is coming to Town – European Medicines Agency (EMA)”