FDA Adds Submission Type to Delayed eCTD Implementation Requirements

FDA Adds Submission Type to Delayed eCTD Implementation Requirements

Posted 25 April 2018 | By Ana Mulero  In the fifth version of US Food and Drug Administration (FDA) final guidance released Wednesday, the agency added a deadline for Type III drug master file (DMF) submissions in electronic common technical document (eCTD) format. The updated guidance—which implements the requirements, under the FD&C Act, for eCTD […]

Bill on Hickenlooper's desk would allow Colo. sales of FDA-approved, pot-based child epilepsy drug

Bill on Hickenlooper's desk would allow Colo. sales of FDA-approved, pot-based child epilepsy drug

DENVER – A bill in Colorado headed to Gov. John Hickenlooper’s desk aims to open up state law to allow pharmacies to sell cannabidiol drugs approved by the U.S. Food and Drug Administration (FDA) and could represent a shift in ideals for some regarding the medical effects of cannabis byproducts. The state Senate unanimously passed House Bill […]

Otsuka finally gets FDA OK for kidney disease drug

Otsuka finally gets FDA OK for kidney disease drug

At the second attempt, Otsuka has been given a green light in the US for tolvaptan, the first drug to be FDA-approved for polycystic kidney disease. The FDA turned down Otsuka’s earlier marketing application for tolvaptan in 2013 due to a lack of clinical evidence that it worked, to the consternation of US patients with […]

FDA Panel Affirms Safety Of Painkiller Celebrex

FDA Panel Affirms Safety Of Painkiller Celebrex

A panel of experts found Wednesday that Celebrex, or celecoxib, is no less safe than two other non-opioid painkillers. Daniel Acker/Bloomberg via Getty Images hide caption toggle caption Daniel Acker/Bloomberg via Getty Images A panel of experts found Wednesday that Celebrex, or celecoxib, is no less safe than two other non-opioid painkillers. Daniel Acker/Bloomberg via […]

As India, China drug industries mature, FDA scrutiny an overhang

As India, China drug industries mature, FDA scrutiny an overhang

Sun Pharmaceutical Industries Ltd., India’s largest generic drugmaker by market share, has spent the last two years stuck in a holding pattern. Operations at a key factory in Halol have been hamstrung by the still-lingering effects of a warning letter Sun received from the U.S. Food and Drug Administration in December 2015. Despite the company’s […]

Vegan Star Will.I.Am Compares The FDA To Drug Dealers

Vegan Star Will.I.Am Compares The FDA To Drug Dealers

Will.I.Am changed his health on a plant-based diet (Photo: Instagram/iamwill) Outspoken vegan star Will.I.Am has shared a video on Instagram, in which he compares America’s Food and Drug Administration [FDA] to drug dealers. He accused the FDA – a US federal agency which regulates food and medicine safety – of ‘allowing bullshit f**d to enter […]

FDA Rejects Anti-Legalization Pharma Co's Cannabis Drug Request

FDA Rejects Anti-Legalization Pharma Co's Cannabis Drug Request

The same drug company that donated $500,000 to a campaign to defeat marijuana legalization in its home state of Arizona in 2016 is now actively fighting to deter competition against its own synthetic THC product. Efforts to extend its exclusive right to manufacture the drug have resulted in a back-and-forth with a federal agency that ultimately […]