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Regulatory Affairs

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.
Posted: October 18, 2017, 12:00 am
This article discusses the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. It offers a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy. The article was based on a presentation given at the 2017 RAPS Convergence, during the medical food session on Modification of Diet Alone (MODA) vs. access and convenience matters.
Posted: October 18, 2017, 12:00 am
While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act, Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended.
Posted: October 18, 2017, 12:00 am
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: October 18, 2017, 12:00 am
Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.
Posted: October 18, 2017, 12:00 am


Prometic today announced that Health Canada has granted priority review status for the NDS the company plans to file for its plasminogen replacement therapy (RyplazimTM) for the treatment of patients with plasminogen deficiency.
Posted: October 19, 2017, 12:00 am
The NDA submission triggers a $15 million milestone payment, payable to FibroGen by AstraZeneca.
Posted: October 18, 2017, 12:00 am
The FDA has previously set February 8, 2018 as the Prescription Drug User Fee Act ("PDUFA") goal date.
Posted: October 18, 2017, 12:00 am
With the FDA granting a priority review, a decision is expected in the first half of 2018.
Posted: October 18, 2017, 12:00 am
LYNPARZA has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer.
Posted: October 18, 2017, 12:00 am


The move comes amid a dizzying series of developments in which Allergan has attempted to shield its best-selling treatment from generic competition.
Author: Ed Silverman
Posted: October 19, 2017, 12:13 pm
To me, a kidney stone wasn't really a big deal. But to my husband, it was a family crisis, and it taught me how medicine has changed me.
Author: Jennifer Adaeze Okwerekwu
Posted: October 19, 2017, 8:30 am
Effective medications that stay active in the body for weeks or months can help people addicted to opioids parlay transitory desires to stop using these drugs into lasting recovery from…
Author: Keith Humphreys
Posted: October 19, 2017, 8:30 am
October is shaping up to be a momentous month for GlaxoSmithKline’s new shingles vaccine, Shingrix. The Food and Drug Administration may approve the vaccine for the U.S. market by the…
Author: Helen Branswell
Posted: October 19, 2017, 8:30 am
The groups say drug makers, wholesalers, and pharmacies will actually raise prices on most Ohioans if the state takes a mandatory discount.
Author: Casey Ross
Posted: October 19, 2017, 8:30 am

Human Resources

While the program could face changes, understanding how it has contributed to the American workforce over the last decade is important. 

Posted: October 18, 2017, 2:53 pm

The cannabis industry is expected to create more jobs in the U.S. by 2020 than manufacturing, utilities or the government — and HR could learn a few things from it.

Posted: October 18, 2017, 2:44 pm

If confirmed, E. Preston Rutledge will lead the DOL division tasked with, among other things, reviewing the now-delayed fiduciary rule.

Posted: October 18, 2017, 2:25 pm

The gap is found in certain geographic areas, but isn’t as massive as generally reported, a new study says.

Posted: October 18, 2017, 2:08 pm

To be the best in their class, employers of all sizes must build a strong, enabling culture.

Posted: October 18, 2017, 2:06 pm