Thursday, January 31, 2013

DOJ - Compliance - Ask Yourself These 5 Questions

Dismissed U.S. attorneys summary
The article below challenges you to think about your people and compliance in the form of 5 questions.

Five Compliance Questions to Ask Yourself, from the DOJ:
"the US Justice Department (DOJ) – in the name of “protecting consumers where they are most vulnerable,” according to Frimpong – is also placing a “focus on people,” since processes and policies (at least publicly-circulated processes and policies) don’t typically break the law; people do. “We know there are enormous cost pressures, but you can’t sacrifice safety under these pressures,” said Frimpong.

To that end, Frimpong recommended that attendees ask themselves five questions about the group of people they work with, to help identify potential problems before they result in an investigation or worse."

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You might also be interested in:

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Tuesday, January 29, 2013

FDA Warning - GermBullet Is An Unapproved Flu Remedy

FDA warns company over unapproved flu remedy - US News and World Report:

"The Boca Raton, Fla.-based company advertises the product as a "proprietary blend of 11 organic botanicals." The company's website claims that "an FDA recognized virology lab" tested the formula and "confirmed that it has the potential capability to kill cold and flu viruses."

But FDA regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations. All new drugs marketed in the U.S. must be submitted for approval to the FDA before they can be sold to consumers. The GermBullet is sold online through retailers like CVS.com and at a handful of small pharmacies and natural food stores in Florida."

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ACIP - 2013 Adult Immunization Schedule

English: Logo of the Centers for Disease Contr...
The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) announced its recommended 2013 adult immunization schedule that includes important updates to the pneumococcal, Tdap (tetanus, diphtheria, and acellular pertussis), and influenza vaccines.

Annals of Internal Medicine | Recommended Adult Immunization Schedule: United States, 2013(2):

"The Advisory Committee on Immunization Practices (ACIP) annually reviews and updates the Adult Immunization Schedule (Figures 1 and 2), which is designed to provide vaccine providers with a summary of existing ACIP recommendations regarding the routine use of vaccines for adults. The Adult Immunization Schedule also includes a table summarizing the primary contraindications and precautions for routinely recommended vaccines (Table). In October 2012, ACIP approved the Adult Immunization Schedule for 2013. This schedule also incorporates changes to vaccine recommendations voted on by ACIP at the 24–25 October 2012 meeting."

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FDA - Foods & Veterinary Medicine Program Reorganized

President Barack Obama signs H.R. 2751, the “F...
SCVNews.com | FDA Reorganizes Foods & Veterinary Medicine Program | 01-28-2013:

"Under the reorganization, the Office of Foods is now the Office of Foods and Veterinary Medicine, led by Michael Taylor, the Deputy Commissioner for Foods and Veterinary Medicine.

The Office of Foods was created in 2009 to elevate leadership on food and feed safety and to reflect the vision that success on food and feed safety requires an integrated approach that leverages resources. This reorganization will further the integration that has already been achieved and better position the program to implement the FVM Strategic Plan for 2012-2016 and the Food Safety Modernization Act, which emphasizes a systematic approach to risk-based priority setting and resource allocation."

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Friday, January 25, 2013

Too Little Reward For Quality - Drives Generic Injectable Shortages

Clinical Pharmacology & Therapeutics - Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages:

"Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments."

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Thursday, January 24, 2013

FDA Inspection - Tips by the FDAzilla Blog

English: FDA Inspector LCDR Teresa Fox (USPHS)...
A good quick primer with some useful links to resources . . .

» 20 Resources to Ace Your Next FDA Inspection FDAzilla Blog:

"FDA inspections.  If part of your job includes preparing your cGMP manufacturing facility to be ready at any second for an FDA inspection.  This page is for you.  Here are our top 20 resources and FAQs for you: . . ."

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You might also be interested in:
Surviving an FDA Inspection - an on-site course that's taught at your location

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FDA Search for Acronyms & Abbreviations - A nice tool!

Follow the link below, to get to the handy FDA Search box, to get definitions of acronyms and abbreviations.


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Wednesday, January 23, 2013

Booze Disrupts Sleep

Booze before bedtime may lead to bad sleep - CBS News:

"The research showed that people were able to fall asleep faster and displayed increases in slow-wave sleep (SWS) -- or deep sleep -- during the first half of the night. SWS consists of stage 3 and 4 of NREM sleep, periods when the body repairs and regenerates tissues, builds bone and muscle and is believed to strengthen the immune system. This is typically known as the rest and restoration part of the sleep.

However, people who drank more alcohol tended to have their sleep interrupted during the second half of the night. What's more, the REM sleep portion of their cycle was disturbed during sleep, including delays in first onset of REM sleep. "

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Ben Venue Signs FDA Consent Decree Over Drug Manufacturing Problems

Ben Venue Signs Consent Decree with FDA Over Drug Manufacturing Problems | Fox Business:

"Ben Venue Laboratories, the contract drug manufacturer whose quality lapses caused a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil and recalls of numerous other drugs, reached an agreement with U.S. authorities governing the company's efforts to fix the problems.

Ben Venue, a Bedford, Ohio, division of Germany's Boehringer Ingelheim, signed a so-called "consent decree" with the Food and Drug Administration, according to a company statement and court documents filed by the Department of Justice in federal court in Ohio.

The consent decree bars Ben Venue from making and selling certain drugs until the company can demonstrate that it has taken certain steps to correct its manufacturing problems, among other requirements."

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Tuesday, January 22, 2013

FDA on Serving Up Safe Buffets

Some great food safety tips from the FDA, on how to serve a buffet when entertaining at home . . .

Consumers > Serving Up Safe Buffets:

"Entertaining is one of the mainstays of the holiday season – and helps commemorate milestone events throughout the year, too. With proper prep, you can be creative and tempt your party guests with an array of fun platters … while still keeping food safety in mind!

Plan a “bacteria–free buffet” with these helpful tips: . . ."

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Friday, January 18, 2013

FDA - Pharma Warning Letters and Notice of Violation Letters

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

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Monday, January 14, 2013

FDA Warning Letters - Common Violations

The author reports six categories of the most common violations . . .

FDA warning letters: the most common violations highlighted | Life Sciences Articles:

"Before the FDA takes enforcement action on negative inspection findings, it issues a warning letter. From an analysis of 87 such letters, we learned a lot about what the FDA is looking for and ways to keep you from receiving a letter yourself. Here is the countdown of the most common violations mentioned in FDA Warning letters."

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Wednesday, January 9, 2013

Dietary Supplement Industry - Vulnerable to FDA Enforcement

Dietary Supplement Industry: Everyone Vulnerable to FDA Enforcement:

"Who is at risk in the dietary supplement industry from the enforcement arm of FDA?

The short answer, says veteran attorney Anthony Young, is everybody.

"We are no longer an unregulated industry in any way," declares Young, a partner with Kleinfeld, Kaplan and Becker, a firm concentrating on the regulation of products subject to FDA jurisdiction."

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Monday, January 7, 2013

FDA - Two Proposed Rules Released to Implement FSMA

Updated October 15, 2016

You might also be interested in:
What to Expect Now that the First Big FSMA Compliance Dates Are Here

- -  original post follows below  - -

FDA Law Blog: On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules:

"FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."

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Wednesday, January 2, 2013

2012 - Top Pharma Acquisitions (AZN, BMY, GSK)

The Top Pharma Acquisitions of 2012 (AZN, BMY, GSK):

"Pharma largely backed off mergers and acquisitions this year, but there were still a couple of deals earning attention. Bristol-Myers Squibb (NYSE: BMY  ) and AstraZeneca (NYSE: AZN  ) made a significant diabetes play. GlaxoSmithKline (NYSE: GSK  ) absorbed a pipeline partner with a small stable of drugs. The deals helped these big pharma players diversify their portfolio and offset revenues lost to patent expirations."

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Tuesday, January 1, 2013

FDA - Food Facility Registration Renewal Deadline Extended - Guidances

Updated Mar 16, 2016

You might have been looking for:
Majority of FDA-registered food facilities now outside the U.S. - Food Safety News

- - -  original post below  - - -

FDA Extends Food Facility Registration Renewal Deadline And Issues Guidance Documents - Food, Drugs, Healthcare and Life Sciences - United States:

"The FDA recently announced that it will defer enforcement of the deadline for the biennial food facility registration renewal from Dec. 31, 2012 until Jan. 31, 2013. The action results from the FDA's delay in opening the registration renewal process from Oct. 1 until Oct. 22, 2013. The FDA is encouraging companies to complete the process early."

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Additional FDA Guidance Documents:
These answer basic questions about the food facility registration process.

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