FGCU softball senior balances EMT training and Regional playHomes For Our Troops grants veteran new home
PUNTA GORDA The Weather Authority helps you prepare for the hurricane season at the 2024 Charlotte County Hurricane Expo With hurricane season less than two weeks away, it’s important to start preparing.
GAINESVILLE FGCU softball senior balances EMT training and Regional play Ahead of NCAA Regional play, FGCU senior outfielder Riley Oakes started EMT training as she works toward being a trauma surgeon.
PUNTA GORDA Homes For Our Troops grants veteran new home Through all the cheers and a community-wide escort, it’s a ‘welcome to your forever home for army sergeant veteran Brandon Rethmel and his family.
ALVA Three dead in triple drowning near the Franklin Lock in Olga The Lee County Sheriff’s Office is responding to a scene of a water rescue where three people were recovered.
SOUTHWEST FLORIDA Beat the Heat: Stay safe during extreme weather The Weather Authority has issued a heat advisory for portions of South, Southeast, and Southwest Florida from 10 a.m. to 8 p.m. on Saturday.
FORT MYERS Leaders discuss possibility of shutting down Caloosahatchee Bridge Should residents endure two years of partial lane closures, or fully shut the Caloosahatchee bridge down for 10 weeks?
GAINESVILLE FGCU softball parents cherish NCAA Tournament experience The parents of the FGCU softball team are relishing seeing their daughters play in the NCAA Tournament.
SOUTHWEST FLORIDA The Weather Authority: Hot, hot, hot Heat advisory in place for Saturday until 8 p.m.
FORT MYERS Fort Myers teen finds dead body in bed of his truck A 16-year-old in Fort Myers drove to school, drove home, drove to the barbershop and back home again. Then, he noticed a swarm of flies in the back of his truck.
Scottie Scheffler facing felony charges; local attorney reacts The attorney we spoke with told us that, at a minimum, we’d spend the night in jail before having our first appearance and getting bail.
GAINESVILLE FGCU softball falls to No. 4 Florida in NCAA Tournament The FGCU softball team couldn’t keep up with the No. 4 Florida Gators as the Eagles drop their first Regional game 6-0 to the Gators.
Summer Safety: Swim safety tips to know before the summer The pool is warming up to be the hot spot for kids and families this summer. It’s now also the number one leading cause of drowning deaths for children ages 1-4 in the state.
FORT MYERS BEACH ‘The Whale’ restaurant to break ground on new building The Whale is a place that has shown great strength and determination.
COLLIER COUNTY Endangered Florida panther deaths surpass 2023 total in 5 months It’s taken wildlife officials just over five and a half months to report finding more dead endangered Florida panthers than in all of 2023.
FORT MYERS FMPD honors 7 officers and 2 K-9s who died in the line of duty dating back to 1930 Nine lives were given, and all nine will remain remembered. A lifetime of gratitude for the fallen officers.
PUNTA GORDA The Weather Authority helps you prepare for the hurricane season at the 2024 Charlotte County Hurricane Expo With hurricane season less than two weeks away, it’s important to start preparing.
GAINESVILLE FGCU softball senior balances EMT training and Regional play Ahead of NCAA Regional play, FGCU senior outfielder Riley Oakes started EMT training as she works toward being a trauma surgeon.
PUNTA GORDA Homes For Our Troops grants veteran new home Through all the cheers and a community-wide escort, it’s a ‘welcome to your forever home for army sergeant veteran Brandon Rethmel and his family.
ALVA Three dead in triple drowning near the Franklin Lock in Olga The Lee County Sheriff’s Office is responding to a scene of a water rescue where three people were recovered.
SOUTHWEST FLORIDA Beat the Heat: Stay safe during extreme weather The Weather Authority has issued a heat advisory for portions of South, Southeast, and Southwest Florida from 10 a.m. to 8 p.m. on Saturday.
FORT MYERS Leaders discuss possibility of shutting down Caloosahatchee Bridge Should residents endure two years of partial lane closures, or fully shut the Caloosahatchee bridge down for 10 weeks?
GAINESVILLE FGCU softball parents cherish NCAA Tournament experience The parents of the FGCU softball team are relishing seeing their daughters play in the NCAA Tournament.
SOUTHWEST FLORIDA The Weather Authority: Hot, hot, hot Heat advisory in place for Saturday until 8 p.m.
FORT MYERS Fort Myers teen finds dead body in bed of his truck A 16-year-old in Fort Myers drove to school, drove home, drove to the barbershop and back home again. Then, he noticed a swarm of flies in the back of his truck.
Scottie Scheffler facing felony charges; local attorney reacts The attorney we spoke with told us that, at a minimum, we’d spend the night in jail before having our first appearance and getting bail.
GAINESVILLE FGCU softball falls to No. 4 Florida in NCAA Tournament The FGCU softball team couldn’t keep up with the No. 4 Florida Gators as the Eagles drop their first Regional game 6-0 to the Gators.
Summer Safety: Swim safety tips to know before the summer The pool is warming up to be the hot spot for kids and families this summer. It’s now also the number one leading cause of drowning deaths for children ages 1-4 in the state.
FORT MYERS BEACH ‘The Whale’ restaurant to break ground on new building The Whale is a place that has shown great strength and determination.
COLLIER COUNTY Endangered Florida panther deaths surpass 2023 total in 5 months It’s taken wildlife officials just over five and a half months to report finding more dead endangered Florida panthers than in all of 2023.
FORT MYERS FMPD honors 7 officers and 2 K-9s who died in the line of duty dating back to 1930 Nine lives were given, and all nine will remain remembered. A lifetime of gratitude for the fallen officers.
MGN Online WASHINGTON (AP) – The Food and Drug Administration is speeding up its review of new drugs, yet often fails to keep track of safety issues with those medicines once they reach patients, according to government investigators. A new Government Accountability Office report released Thursday outlines a host of shortcomings in FDA’s system for tracking drug safety issues, including incomplete, outdated and inaccurate information. At the same time, the agency is making significant use of mechanisms to streamline its reviews, especially for drugs to treat deadly diseases like cancer. The new findings come as FDA leaders emphasize the speed and efficiency with which agency scientists can approve experimental drugs. Last year the agency approved 45 first-of-a-kind drugs – the highest number in 19 years – with most reviewed in approximately eight months. More than half received some form of specialized review to speed their path to market. But the GAO says the agency often fails to keep track of follow-up studies required for such high-priority drugs. For instance, GAO found that the FDA was late in reviewing more than half of the 1,400 follow-up studies it had requested or required of drugmakers between 2008 and the fall of 2013. Those studies are critical for spotting safety issues that may not emerge until after patients start taking the drugs. Congresswoman Rosa DeLauro, D-Conn., who commissioned the report, said the findings suggest the FDA is “shifting more of the safety risk to consumers.” “The GAO report clearly highlights that FDA is not doing its due diligence in tracking drug safety issues and post-market studies that are critical in ensuring patient safety,” DeLauro said in a statement. The Department of Health and Human Services, which oversees the FDA, said the agency is conducting internal evaluations to improve its computerized tracking system, which it acknowledged is challenging to update. The FDA also revealed to GAO investigators that the majority of potential safety issues identified by staffers had not been uploaded to its archival drug tracking system. “Given the high workload of its review staff it had prioritized identifying, assessing and addressing potential safety issues over administrative tracking,” the GAO reported, based on interviews with FDA officials. The report recommends FDA develop comprehensive plans for overhauling its database so it can be more easily updated with accurate, timely information. The GAO found that a quarter of all drug applications approved by the FDA used at least one pathway to speed review, based on data from late 2006 to 2015. The FDA currently has four systems for expediting drug reviews. Features of those programs include shorter study requirements for promising new drugs and extra meetings with FDA staff. Earlier in the week, a Senate panel voted to endorse President Obama’s nominee to be the next FDA Commissioner, Dr. Robert Califf. A prominent cardiologist and researcher, Califf is a leading authority on designing drug studies. He is currently the FDA’s second-highest ranking official.