Wednesday, February 27, 2013

2013 FDA Orange Book - New!

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

- -  original post follows below  - -

FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (pdf) has just been posted on the FDA's website.

It's the 33rd edition.

It lists products that have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume is current through December 31, 2012.

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Friday, February 15, 2013

IOM Suggests Other Alternatives To The Word "Counterfeit" re: Drugs

FDA Law Blog: Don’t Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs:

"IOM recommended excluding the use of the term “counterfeit.”  There is disagreement in the international regulatory community as to whether “counterfeit” refers broadly to something that is “not what it claims to be,” or whether the narrower, legal definition, which focuses on trademark infringement, is applicable.  The IOM report forgoes the use of the term “counterfeit,” and instead encourages the use of the terms “substandard,” “falsified,” and “unregistered.”  “Substandard” drugs are “those that do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier.” "

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FDA Seizes Illegal Dietary Supplements in FL

Fda
FDA Seizes Illegal Dietary Supplements in FL | Designated Representative and Exemptee:

"WASHINGTON: FDA seizes illegal dietary supplements in Florida - Business Breaking News - MiamiHerald.com:

"Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.

Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards."

For additional details:
FDA Warning Letters - Globe All Wellness, LLC 2/6/12

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Tuesday, February 12, 2013

ADA & FDA - Revised Recommendations for Dental X-Rays

English: Examples of dental radiography
English: Examples of dental radiography (Photo credit: Wikipedia)
X-Rays - American Dental Association - ADA.org:

"Guide to Patient Selection and Limiting Radiation Exposure

The ADA, in collaboration with the FDA, developed recommendations for dental radiographic examinations to serve as an adjunct to the dentist's professional judgment of how to best use diagnostic imaging. Radiographs can help the dental practitioner evaluate and definitively diagnose many oral diseases and conditions. "

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Reference:
Dental Radiographic Examinations: Recommendations for Patient Selection and Limiting Radiation Exposure (pdf)

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Monday, February 11, 2013

Titan Medical Enterprises Shut Down for GMP Violations

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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ICH Photosafety - FDA EU Draft Guidance

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences:

"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 draft guidance:
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - DRAFT CONSENSUS GUIDELINE - PHOTOSAFETY EVALUATION OF PHARMACEUTICALS - S10 (pdf)

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Tuesday, February 5, 2013

FDA Joins Celebration of American Heart Month

Celebrating American Heart Month—Making Heart Healthy Choices in 2013 | FDA Voice:

"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

Device-makers slam Medicare competitive bidding expansion - The Hill's Healthwatch:

"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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