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FDA announces new 'streamlined' application for investigative drugs

FDA announces new 'streamlined' application for investigative drugs
June 2, 2016

The FDA has released a new application for investigative drugs that it says will cut the amount of time physicians spend filling out such requests, as part of a larger effort to “streamline” the process of providing medications still undergoing regulatory review to their patients with severe illness.

The final Individual Patient Expanded Access Investigational New Drug Application can be used by physicians to request expanded access to investigational drugs for patients who suffer from serious or immediately life-threatening diseases, in the absence of any comparable or satisfactory alternative treatment. According to a statement released by FDA Commissioner Robert Califf, MD, the new form is one part of a larger effort to improve the process by which physicians request “compassionate use” of investigative drugs.

South Carolina legislators override veto of Eye Care Consumer Protection Law

May 20, 2016
In South Carolina, legislators overrode an executive veto by Gov. Nikki Haley for S. 1016, the Eye Care Consumer Protection Law, on May 16. On May 18, by a 39 to 3 vote…

BLOG: Dissecting the Medicare Access and CHIP Reauthorization Act

May 16, 2016
Out on the lecture circuit last week, I mentioned MACRA and was met with a sea of blank stares. The Medicare Access and CHIP Reauthorization Act of 2015, which provides…

NAD recommends B+L discontinue certain claims for Ultra lenses

April 25, 2016
The National Advertising Division determined that Bausch + Lomb can support advertising claims that indicate the presence of polyvinylpyrrolidone, which attracts and…
In the Journals

Study shows nearly 10 million highly myopic adults in US

June 27, 2016
Researchers determined a population burden of approximately 9.6 million adults with high myopia, 817,829 adults with…
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Optometry pioneer Alden N. Haffner, OD, dies at 87

June 23, 2016
Alden N. Haffner, OD, PhD, FAAO , passed away at the age of 87 on June 22, according to an announcement from the…
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In the Journals

AAO revises screening guidelines for chloroquine, hydroxychloroquine retinopathy

June 23, 2016
The American Academy of Ophthalmology revised its recommendations on screening for chloroquine and hydroxychloroquine…
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FDA News

FDA announces new 'streamlined' application for investigative drugs

June 2, 2016
The FDA has released a new application for investigative drugs that it says will cut the amount of time physicians spend filling out such requests…

South Carolina legislators override veto of Eye Care Consumer Protection Law

May 20, 2016
In South Carolina, legislators overrode an executive veto by Gov. Nikki Haley for S. 1016, the Eye Care Consumer Protection Law, on May 16. On May…

BLOG: Dissecting the Medicare Access and CHIP Reauthorization Act

May 16, 2016
Out on the lecture circuit last week, I mentioned MACRA and was met with a sea of blank stares. The Medicare Access and CHIP Reauthorization Act of…

NAD recommends B+L discontinue certain claims for Ultra lenses

April 25, 2016
The National Advertising Division determined that Bausch + Lomb can support advertising claims that indicate the presence of polyvinylpyrrolidone…

Meeting News CoverageVideo

Naidoo introduces global children's vision program

April 19, 2016
NEW YORK – “The Our Children’s Vision global campaign has been launched to ensure we make child eye health accessible to children…

Meeting News Coverage

Essilor supports efforts to address children’s vision

April 19, 2016
NEW YORK – “Uncorrected refractive error is probably the biggest disability in the world,” Jayanth Bhuvaraghan said…

In the JournalsPerspective

Physicians lack clarity on FDA approvals, ‘breakthrough therapy’

April 18, 2016
Physicians demonstrated limited understanding of the FDA approval process and the meaning of the “breakthrough therapy” designation…

BLOG: Who inspires you?

April 14, 2016
I have a tendency to be influenced by the people that I meet and talk with. I often find the stories of the events and happenings of other…

AOA supports contact lens prescription verification, patient safety bill

April 13, 2016
The American Optometric Association announced its support for the Contact Lens Consumer Health Protection Act of 2016, introduced by Sen. Bill…

Video

JJVC replaces unilateral pricing policy

April 13, 2016
Johnson & Johnson Vision Care Inc. announced that it has discontinued its unilateral pricing policy and is replacing it with new programs to…

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