Press Announcements > Court shuts down U.S. operations of California drug, dietary supplement manufacturer:
"The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice for drugs (Drug cGMP) and for dietary supplements (Dietary Supplement cGMP). The court also found that the defendants violated federal law by distributing unapproved new drugs in violation of the Act. Prior to entry of the court’s order, Titan Medical Enterprises manufactured and domestically distributed a variety of drugs and dietary supplements." . . .
Drug cGMP includes practices and systems required to be adopted in the manufacture and testing of pharmaceuticals. Drug cGMP outlines the aspects of production and testing that can impact the quality of a product.
Similarly, Dietary Supplement cGMP regulations require dietary supplement manufacturers to ensure quality in their dietary supplements by appropriately controlling all aspects of their processes and procedures to ensure a supplement meets minimal quality standards and is not adulterated by the presence of contaminants.
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Monday, February 11, 2013
Titan Medical Enterprises Shut Down for GMP Violations
ICH Photosafety - FDA EU Draft Guidance
"The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.
“The S10 draft guidance document clarifies some points in the current EMA and FDA guidance that are known weaknesses, based on accumulated information and experience since those documents were issued in the mid-2000s,” Doug Learn, director of photobiology at Charles River, told In-Pharmatechnologist.com."
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Read the guidance (updated link):
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Tuesday, February 5, 2013
FDA Joins Celebration of American Heart Month
"Each year, nearly half of all Americans make New Year’s resolutions. They often include losing weight, starting an exercise program, quitting smoking, and making healthier food choices—all of which contribute to a heart-healthy lifestyle. February is American Heart Month, and the timing couldn’t be better to make these lifestyle changes, especially since heart disease is the leading cause of death in the U.S.
FDA joins in the commemoration of American Heart Month by highlighting agency initiatives to help Americans reduce their risk of heart disease."
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Saturday, February 2, 2013
CMS Issues Sunshine Rule - Applies to Drug and Device Manufacturers
CMS Issues Sunshine Rule:
"The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, "finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children's Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS," the statement explained. "CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.""
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Physician Payments Sunshine Act (the "rule") - the Federal Register pre-publication version
Physician Payments Sunshine Act (the "rule") - the official Federal Register published version
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Friday, February 1, 2013
Device-Makers Critical of Medicare Competitive Bidding
"The medical-device lobby is railing against a new expansion of Medicare's competitive bidding program for durable equipment, a policy projected to save billions of dollars for beneficiaries and the Part B Trust Fund by 2022.
The Advanced Medical Technology Association (AdvaMed) said that the expansion could deprive patients of their preferred medical tools and tests.
"The competitive bidding program is built in such a way that the lowest bid — which may not be the right bid — may compromise patient access to products best suited for their needs," AdvaMed President Stephen Ubl said Thursday in a statement. "
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