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Latest China Cybersecurity Proposal Could Impose Heightened Scrutiny On Biopharma

Drugmaking is among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.

Cybersecurity Legislation

Medically Senseless: Why EU Pediatric Investigation Plans Should be Abandoned

Most clinical trials required under EU pediatric investigation plans are medically senseless, and many cause harm to patients, argues consultant Klaus Rose. This is a challenge not only for the pharmaceutical industry but for regulators and wider society as well.

Pediatrics Europe

OTC Monograph User Fees Still On The Table, But Not In Legislation

FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.

Consumer Legislation

Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House

The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.

FDA Drug Approval Standards

Not Quite FDARA Add-Ons: Right-To-Try, Patient Experience, Opioid Measures Also Clear US Senate

Senate passage of the FDA user fee package without amendments was enabled by unanimous consent votes on controversial right-to-try legislation that is toned down from its initial version, as well as two other bills.

Legislation FDA

India’s Malaria Elimination Target May Be Tough To Meet, Say Experts

India has announced a plan to eliminate malaria by 2027, three years ahead of a global target set by the World Health Organization, but the deadline may be tough to meet without an accurate fix on the annual number of cases of the mosquito-borne disease, experts say.

Policy Legislation
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