Tuesday, November 17, 2015

Multiple cups of coffee a day linked to lower risk of death - UPI.com

Read the full article: Multiple cups of coffee a day linked to lower risk of death - UPI.com:

"Unlike previous studies, however, researchers also considered smoking. When taking cigarettes out of the mix -- because many people who smoke also drink a lot of coffee -- the data showed that 1.1 to 3 cups per day led to an 8 percent drop in mortality and 3.1 to 5 cups per day had a 15 percent lower risk of death. Those drinking five or more cups were 12 percent less likely to die."

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Catalent stops production at French plant, brings in law enforcement after it twice detects tampering - FiercePharma

Read the full article: Catalent stops production at French plant, brings in law enforcement after it twice detects tampering - FiercePharma:

"U.S.-based Catalent ($CTLT) has halted production at a softgel capsule manufacturing facility in France at the request of regulators after several incidents in which it appears someone within the plant purposely mixed the wrong capsules into batches. The company said it is working with French law enforcement and regulators to find out what happened."

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Monday, November 16, 2015

In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI - Free Tips

Read the full article for free tips: In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"For many medical device companies, it's a scary idea that an FDA inspector could show up at your reception desk tomorrow—or even today. Device executives need to ensure that everyone, from their regulatory affairs team to their receptionist, know how to interact with FDA personnel."

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#free #tips

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Thursday, November 12, 2015

FDA approves 3-D printing for pills - 10 News

Read the full article:  FDA approves 3-D printing for pills -  10 News: Tampa Bay Sarasota:

"The FDA has given approval to a new kind of pill – the first medicine made with a 3-D printer.

The drug is an anti-epileptic drug called Spritam. It’s the same drug as the widely prescribed Levetiracetam or Keppra."

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Tuesday, November 10, 2015

There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App - FDA Law Blog

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)


Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

Read the full article: FDA Law Blog: There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App:

" . . allows users to search by Active Ingredient, Proprietary Name, Applicant Holder, Application Number, and Patent Number.  Search results are displayed with tabs showing listings in the Prescription Drug Product List, the Over-the-Counter Drug Product List, and the Discontinued Drug Product List sections of the Orange Book.  Each drug product listing links to the same patent and exclusivity information appearing in the paper and electronic versions of the Orange Book, and . . . "

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You might also be interested in:
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Friday, November 6, 2015

Injections given every 8 weeks suppress HIV just as well as daily pills, trial finds - ScienceAlert

Read the full article: Injections given every 8 weeks suppress HIV just as well as daily pills, trial finds - ScienceAlert:

"Formulated to be long-acting and injected together, these two drugs suppressed the virus at a comparable rate to a combination of similar-acting pills taken daily. Patients received one shot either every four weeks, or every eight weeks, and the virus suppression rates were basically the same, although patients with monthly injections complained more about pain at the injection site – the most common side effect of this treatment."

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Monday, November 2, 2015

Death Rates Rising for Middle-Aged White Americans, Study Finds - The New York Times

Read the full article: Death Rates Rising for Middle-Aged White Americans, Study Finds - The New York Times:

"With the pain and mental distress data, Dr. Deaton said, “we had the two halves of the story.” Increases in mortality rates in middle-aged whites rose in parallel with their increasing reports of pain, poor health, and distress, he explained. They provided a rationale for the increase in deaths from substance abuse and suicides."

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