While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading →

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more … Continue reading →

Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … Continue reading →

Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency … Continue reading →

Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, … Continue reading →

Saab's future has hit another major snag. Plus: A new Toyota convertible sports car hybrid!

The flower-power generation definitely couldn't afford this VW Bus. Plus: the rest of the week's car news.

Infiniti is showing off its upcoming seven passenger crossover and we get behind the wheel of a Dodge Challenger 392 HEMI SRT8.

This week: A Blue Angels Mustang, a new Magnum and a big hello to Augusta, Ga.

Plus: The Rascal Flatts Corvette, Chevy solar power charging stations and the rest of the week's automotive news.

Plus: Chrysler minivans recall, the SRT High Performance Tour and Fiat 500 by Gucci.

Plus: Cadillac Ciel Concept, weekend car events and more.

This week: New concept cars, a turbine Batmobile, good news for U.S. automakers and holiday weekend car events.

Plus: Pink Camaro pace car, weekend car events.

Plus: Lots of other fun iron from Frankfurt and Ford's bold new infotainment venture.

Plus: Ford's new Police Interceptors, weekend car events.

This undated photo shows the Space and Upper Atmosphere Research Commission's rover during a test. — APP/File

In a major development, the Space and Upper Atmosphere Research Commission has announced its collaboration on a groundbreaking lunar...

HBO boss defends J.K. Rowling amid her divisive views

A new series about Harry Potter is in the works. However, questions have been raised over J.K. Rowling's involvement in the making amid her controversial views on gender.

HBO chief Casey Bloys, meanwhile, set aside these concerns...

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I’m in my mid-20s and struggle to remain body-positive. I have been working out and taking care of my diet, but this feeling of not looking the best just keeps me mentally exhausted.

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Scheme to give subsidies worth INR36.79 billion on e-two wheelers, e-three wheelers, e-ambulances and e-trucks

IAF capitalises on anger over Israel and new laws, securing historic gains in a changing political landscape

Rex agreed to purchase planes for $US2 million, paying a $200,000 deposit but failed to make further payments in 2020

Alberto Fujimori leaves behind a mixed legacy of growth and controversy after battling cancer

Over US missile deployment in Japan, Moscow and Beijing will jointly engage in 'double counteraction,' says Zakharova

A 2020 report had recommended investigations into 19 soldiers for the killing of 39 Afghan civilians and prisoners.

Transport for London said it was contacting around 5,000 customers whose bank account data may have been accessed

It weakened from a Category 2 hurricane to a tropical depression as it moved northeastward over central Mississippi

Harris criticised Trump’s legal woes, foreign policy, mostly on Ukraine, while Trump attacked her position on Israel

Protest sparked by Israeli airstrike on "humanitarian safe zone" in Gaza that killed at least 40 civilians

US Justice Dept announces Haimovich's actions include shipment of components with missile technology applications

Wayne Borg, Neom media executive, reportedly continues to make offensive remarks despite complaints.

Afghan girls are part of a TV channel that is broadcasting the entire Afghan curriculum for girls out of school

From New York to Pennsylvania, solemn ceremonies mark the 23rd anniversary of the 9/11 attacks

Women, children among casualties with six of the victims being staff members of UNRWA including the shelter's manager

Greece has one of Europe's lowest fertility rates, a dire demographic state driven by a decade-long economic crisis

Journalists looked to report inside the Kursk region after a Ukrainian cross-border incursion

Blinken promised to review Kyiv's long-standing request for using Western-supplied weapons to strike Russian targets

Separately, Indian FM said India's economic relationship with China has been very "unfair" and "imbalanced"

Top court and electoral, military officials among 16 targetted as US aims to push Maduro into negotiations

More than 100 people remain missing, while some 800 people have been injured

Spanish FM Jose Manuel Albares will host the meeting with EU officials and Arab-Islamic Contact Group for Gaza

The Motion Picture Association (MPA) continues to play a key role in expanding global site blocking efforts. After helping to establish a voluntary site blocking agreement in the Philippines, the MPA also filed the first complaints under the new rule. Torrent site YTS was the first target, followed by popular pirate streaming sites SFlix and MyFlixer this week.

From: TF, for the latest news on copyright battles, piracy and more.

Prompted by concerns aired by photographers, French telecoms regulator Arcom sought to evaluate content recognition tools deployed at online content-sharing platforms. Meta's Rights Manager and Pinterest's Claim Portal were of particular interest, but both companies denied Arcom's request to measure their effectiveness. Despite the regulator's authority under law, private agreements with rightsholders took priority.

From: TF, for the latest news on copyright battles, piracy and more.

Amazon is cracking down on pirate streaming apps that offer unauthorized access to Prime Video content. The company recently filed DMCA takedown notices with GitHub to remove APKs associated with popular apps such as PikaShow, Castle, and FlixFox. Interestingly, the takedown requests were made on behalf of Amazon Seller Services, an Indian subsidiary not typically linked to Amazon's streaming platform.

From: TF, for the latest news on copyright battles, piracy and more.

Critics of Italy's Piracy Shield are not difficult to find but, with its powerful and influential proponents rarely far away, getting heard is a considerable challenge. Not to mention getting anything done. After calling for the platform's suspension and meeting resistance in the wake of the recent Google Drive blocking blunder, AGCOM board member Elisa Giomi has gone public with a laundry list of concerns. It pulls zero punches.

From: TF, for the latest news on copyright battles, piracy and more.

Pirate streaming site Braflix burst onto the scene last year, offering a vast library of movies and TV shows via a user-friendly interface. With millions of monthly visits the site was destined to profit from the demise of several large competitors. The opposite happened. Facing legal pressure, Braflix has decided to throw in the towel instead.

From: TF, for the latest news on copyright battles, piracy and more.

Rightsholders have asked Google to remove more than 10 billion 'copyright infringing' URLs from its search results. The search engine doesn't celebrate the milestone in any way, but the takedown notices document intriguing shifts in volume over time, as well as shifting takedown interests.

From: TF, for the latest news on copyright battles, piracy and more.

A lawsuit filed in the U.S. claims that a pirate IPTV seller adopted a novel marketing strategy to support a business with 450,000 subscribers . According to the plaintiffs, the owner of the service "held himself out as a Chicago-area law enforcement officer" to "mitigate potential concerns" over the unlawfulness of his business. A theoretical damages claim of more than a billion dollars, plus an allegation of wiretapping, makes this case a little more spicy than most.

From: TF, for the latest news on copyright battles, piracy and more.

After 15+ years of blackholing IP addresses and making the Domain Name System tell more lies than Pinocchio, some may wonder whether site-blocking is harming prospects of a future open internet. Confirmation that piracy blocking tests are now being conducted at the internet's core routers isn't a surprise. It's only the internet's spinal column, so what could possibly go wrong?

From: TF, for the latest news on copyright battles, piracy and more.

Cloudflare is urging the EU Commission to exclude the company from its upcoming Piracy Watch List, despite requests from several rightsholder groups for its inclusion. The American company says it's committed to addressing piracy concerns but not at the expense of user privacy and security. Instead, the European Commission should ensure that its Piracy Watch List does not become a tool for advocating policy changes.

From: TF, for the latest news on copyright battles, piracy and more.