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ACI’s FDA Boot Camp, March 9-11, 2016 – Top Reasons to Attend

January 20th, 2016
in Pharmaceuticals / Biotech / Life Sciences |

ACI’s FDA Boot Camp – Top Reasons to Attend 

Breaking News – Pacira First Amendment Case Settles

December 22nd, 2015
in Pharmaceuticals / Biotech / Life Sciences |

Published on Drug and Device Law on December 15, 2015

We learned about it yesterday from a reporter, but were sworn to secrecy until today.  Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls “favorable resolution.” Pursuant to the settlement agreement, the FDA is formally rescinding its unfortunate warning letter that attempted a retroactive reduction in the scope of the indications of Exparel’s (the drug at issue) approval. [Read More] (more…)

ICMAD Supports The Introduction of The Safe Cosmetics Modernization Act – Nov 19, 2015

November 20th, 2015
in Pharmaceuticals / Biotech / Life Sciences, Press Release |

Press Release Published by ICMAD on November 19, 2015

The Independent Cosmetic Manufacturers and Distributors (ICMAD) association is proud to support legislation introduced today by U.S. Congressman Pete Sessions (R-TX), H.R.4075, The Safe Cosmetics Modernization Act. H.R.4075 modernizes and improves the Food and Drug Administration’s ability to assure the safety of cosmetic products by examining ingredient safety, establishing manufacturing processes and tracking and quickly addressing adverse health impacts from potentially unsafe products and requiring that all manufacturers be registered with the FDA. [Read More] 

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American Conference Institute’s 3rd Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products

ACI is pleased to partner with ICMAD (Independent Cosmetic Manufacturers and Distributors) on the Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products, taking place on March 7-9, 2016 at The Carlton Hotel in New York City. Click here to learn more about the event, which will provide you with the critical information you need to:

  • Review the provisions of the Personal Care Products Safety Act and The Safe Cosmetics Modernization Act
  • Analyze when a cosmetic product must also meet the FDA requirements for OTC drugs
  • Understand when you may need FDA approval for a beauty device
  • Explore legal and regulatory enforcement activity at the state level
  • Demystify retailer requirements for cosmetic and personal care products
  • Design strategies for trade dress protection for packaging
  • Examine Prop 65 reform in California
  • Improve claim substantiation efforts by monitoring enforcement activity at the federal and state level as well as litigation from private parties
  • Comprehend FDA’s jurisdiction over social media marketing tactics for cosmetic products

Register before January 15, 2016 for Advance Pricing by visiting www.AmericanConference.com/Cosmetics or calling 888-224-2480.

Current Good Manufacturing Practices: Drug and Biologics

November 20th, 2014
in Legal Conferences, Pharmaceuticals / Biotech / Life Sciences |

Complimentary presentation from ACI’s 23rd FDA Boot camp.

Highlights from this presentation:

- FDA’s GMP  philosophy

- Substantive drug areas

- Sources of GMPs

- FDA Inspection triggers

- Typical investigation activities and much more…

 

 

(more…)

ACI’s 5th Annual conference on Biosimilars

May 15th, 2014
in Pharmaceuticals / Biotech / Life Sciences |

biosimilars

 

When: Wednesday, June 04 to Friday, June 06, 2014

Where:  InterContinental New York Barclay, New York, NY

To learn more, visit:  AmericanConference.com/biosimilars 

 

(more…)

Are Sugary Drink Warnings Coming to California?

April 21st, 2014
in Food and Beverage, Legal Conferences, Litigation |

by Jordan Grotzinger, Originally Published on consumerproductscounselor.com 

California isn’t exactly known as a business-friendly state.  In some ways, the governor has tried to change that.  He’ll have an interesting choice to make if a recently-passed senate bill reaches his desk.

(more…)

Weekly Industry News – Pharma & Healthcare

March 17th, 2014
in Healthcare, Legal Conferences, Pharmaceuticals / Biotech / Life Sciences |

Pharma & Healthcare – the latest on FDA’s proposed generic drug labeling rule, FDA bans imports from India’s Sun Pharma and more.

(more…)

Weekly Industry News: Pharma & Healthcare

February 10th, 2014
in Healthcare, Legal Conferences, Litigation, Pharmaceuticals / Biotech / Life Sciences |

Pharma & Healthcare – the latest on Pfizer Inc v. Teva Pharmaceuticals, the USFDA imposes penalties on Indian pharma cos’ and more.

 

FDA panel could give Bayer painkiller an edge over rivals from Pfizer, J&J by Tracy Staton Published on  FiercePharma.com

What if every drug in a class posed a risk to the heart–all except one? That’s the question we could soon be asking about nonsteroidal anti-inflammatories, or NSAIDs, among the most commonly used drugs in the world… [ Read More ]

‘USFDA has imposed disproportionate penalties on Indian pharma cos’ by Amiti Sen Published on The Hindu Business Line

Reacting strongly to the recent string of actions against Indian pharmaceutical companies by the US Food & Drug Administration (FDA), India has said that in some cases the authority has imposed disproportionately strong penalties…[ Read More ]

Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2014) by Andrew Williams Published on jdsupra.com

The standard of review at the Federal Circuit is important.  Even though it often appears like cases are re-litigated at the Appeals Court, it is actually very difficult (or at least should be) to overturn a lower court’s factual determinations…[ Read More

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FDA Steps up and forces recall of OxyElite Pro after a death and kidney failure in Hawaii

November 20th, 2013
in Food and Beverage, Legal Conferences, Litigation |

Expert Guest Entry  by Bill Marler, Originally Posted on MarlerBlog

From our good friends at the FDA:

Following actions by the Food and Drug Administration (FDA), a Texas-based company has agreed to recall and destroy a dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.

In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.

“As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC),” said Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs. “Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace.”

FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.

The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.

While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.

Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.

After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).

“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” said Fabricant. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”

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A Bunch of Listeria Recalls – Are there Illnesses?

October 29th, 2013
in Expert Guest Blog Entries, Food and Beverage, Legal Conferences |

Expert Guest Entry by William (Bill) Marler , Originally posted on MarlerBlog

On October 22, 2013, the FDA reported that Reser’s Fine Foods of Beaverton, OR was recalling approximately 109,000 cases of refrigerated ready-to-eat products because it may be contaminated withListeria monocytogenes.  The recalled refrigerated ready-to-eat products were distributed nationwide and Canada.

It reported:  NO illnesses have been reported to date.

On October 24, 2013, the FDA reported that Boston Salads and Prepared Foods of Boston, MA was voluntarily recalling prepared salads, because they have the potential to be contaminated with Listeria monocytogenes.  Product was distributed throughout the MA, CT, RI, VT, and ME states to wholesale and food service distributors, and retail stores.

It reported:  There has been no illness or complaints related to this recall.

On October 25, 2013, the FISS reported that Garden Fresh Foods of Milwaukee, WI was recalling approximately 103,080 additional pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes.  The company was recalling these products in addition to the 25,748 pounds of similar products that were recalled on Sept. 25 and Oct. 17, 2013.

It reported:  FSIS and the company have not received reports of illnesses due to consumption of these products.

On October 25, 2013, the FSIS reported that Taylor Farms of Jessup, MD was recalling approximately 5,084 pounds of broccoli salad kit products.  The kits contain salad dressing in packets that were the subject of a Food and Drug Administration (FDA) recalldue to concerns about possible Listeria monocytogenes contamination.  The salad kits were shipped to distributors and retail locations (delis) for consumer purchase in Connecticut, Delaware, Maryland, Massachusetts, New Jersey, New York and Vermont.

It reported: FSIS, FDA and the company have received no reports of illnessesassociated with consumption of these products.

On October 26, 2013, the FSIS reported that Reser’s Fine Foods of Topeka, KS was expanding its recall of chicken, ham and beef products to include all products produced between Sept. 5 and Oct. 9, 2013. This was in addition to the 22,800 pounds of product recalled on Oct. 22, 2013. The products are being recalled due to possible contamination with Listeria monocytogenes.

It reported:  FSIS and the company have not received reports of illnesses due to consumption of these products.

Then on October 26, 2013 the FDA reported that Reser’s Fine Foods of Beaverton, OR was voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes.  The recalled refrigerated ready-to-eat products were distributed nationwide and Canada.

Then it changed the wording regarding illnesses to:  There are no confirmed illnessesassociated with these products.

Illnesses linked to the above recalls or not?

 

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