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1
FDA Issues Draft Guidance on Affordable Care Act Prescription Drug Sample Transparency Program: Reporting Deadline Informally Extended to October 1, 2012
Until at least October 1, 2012, the FDA does not intend to object if manufacturers and authorized distributors of record do not submit the information required under the prescription drug sample transparency program.
United States
13 Apr 2012
2
Centers For Medicare And Medicaid Services Releases Proposed Rule On Reporting And Returning Of Overpayments
The U.S. Centers for Medicare and Medicaid Services (CMS) released a long-anticipated proposed rule on reporting and returning of overpayments on February 16, 2012.
United States
14 Mar 2012
3
FDA Issues Draft Guidance For Notification Of Issues That May Result In Prescription Drug Shortage
On February 27, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance encouraging manufacturers of prescription drug and biologic products to voluntarily notify FDA of issues that may result in a shortage of the product in the U.S. market or potential disruption in the supply.
United States
7 Mar 2012
4
FDA Issues Proposed Rule Regarding Citizen Petitions And PSAs Related To Section 505(b)(2) Applications Or ANDAs
As part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) enacted on September 27, 2007, Congress added Section 505(q) to the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 355(q)).
United States
10 Jan 2012
5
FTC Steps Up Enforcement On Health-Related Claims In Advertising
In a recent settlement with Reebok, the U.S. Federal Trade Commission (FTC) clarified that it will impose substantial penalties, including restitution to consumers, on companies that make health-related claims without an adequate basis.
United States
2 Nov 2011
6
New FDA Guidance For Industry On Implementation Of Fee Provisions Of The Food Safety Modernization Act
On October 6, 2011, the U.S. Food and Drug Administration (FDA) announced in the Federal Register its issuance of a question-and-answer guidance document related to the implementation of the fee provisions of the Food Safety Modernization Act of 2011 (FSMA).
United States
16 Oct 2011
7
FDA Publishes Final Guidance For Industry On Applications For Nonprescription Drug Products
The U.S. Food and Drug Administration (FDA) recently released a guidance on "Time and Extent Applications for Nonprescription Drug Products" (the "Guidance").
United States
10 Oct 2011
8
FDA Issues Compliance Policy Guide That Provides Potential Business Advantage For Filing New Drug Application For Marketed, Unapproved Drug
On September 19, 2011, the U.S. Food and Drug Administration (FDA) issued a Compliance Policy Guide (CPG) titled "Marketed Unapproved Drugs," which revises the FDA's 2006 CPG regarding the same topic.
United States
6 Oct 2011
9
U.S. District Judge Rejects FDA's Attempted Regulatory Authority Over Compounding Pharmacies In United States v. Franck's Lab, Inc.
On September 12, 2011, the U.S. District Court for the Middle District of Florida in United States v. Franck's Lab, Inc. denied a request by the U.S. Food and Drug Administration ("FDA") for an injunction and summary judgment against a compounding pharmacy.
United States
26 Sep 2011
10
FDA Issues Draft Guidance For Industry Tablet Scoring
On August 31, 2011, the U.S. Food and Drug Administration ("FDA") issued a draft guidance for sponsors of new drug applications ("NDAs") and abbreviated new drug applications ("ANDAs") providing criteria for evaluating and labeling of tablets that have been scored.
United States
8 Sep 2011
11
FDA Issues Fee Rates Under Food Safety And Modernization Act For Domestic And Foreign Facility Reinspections, Failure To Comply With Recalls, And Importer Reinspection
The Food Safety and Modernization Act (FSMA) provides that the U.S. Food and Drug Administration (FDA) assess fees for certain domestic and foreign facility reinspections, failure to comply with recall orders, and importer reinspections.
United States
16 Aug 2011
12
FDA's Interim Final Rules For The Food Safety Modernization Act
The U.S. Food and Drug Administration (FDA) issued two interim final rules, published in the "Federal Register" on May 5, 2011. The first rule implements section 207 of the Food Safety Modernization Act (FSMA) related to the criteria for ordering administrative detention of human or animal food.
United States
12 Jul 2011
13
U.S. Supreme Court Holds That State-Law-Based Failure-to-Warn Claims Are Federally Preempted Against Generic Drug Manufacturers
On June 23, 2011, the U.S. Supreme Court issued a decision in Pliva, Inc. v. Mensing, holding that state-law claims against generic drug manufacturers are federally preempted pursuant to the Supremacy Clause of the U.S. Constitution.
United States
27 Jun 2011
14
FDA's Guidelines For Petitions Filed Under Section 505(q) Of Food, Drug, And Cosmetic Act
The U.S. Food and Drug Administration (FDA) recently published its guidelines related to citizen petitions and petitions for stays of action under section 505(q) of the federal Food, Drug, and Cosmetic Act (a "Petition").
United States
22 Jun 2011
15
CMS: Proposed Rule For States On Medicaid Fee-For-Service Rate-Setting Procedures
The U.S. Centers for Medicare and Medicaid Services (CMS) published in the May 6, 2011, Federal Register (76 Fed. Reg. 26342) a proposed rule establishing a transparent process that states would be required to follow to change Medicaid payment rates, as well as procedures to ensure ongoing access to care for Medicaid beneficiaries.
United States
13 May 2011
16
FDA: Liquid OTC Drugs With Poorly Labeled Measuring Devices May Constitute Misbranding
The FDA issued its final guidance relating to over-the-counter liquid drug products that are sold with measuring devices, such as spoons, cups or droppers.
United States
11 May 2011
17
FDA Drafts Pharma Industry Guidance for Postmarketing Studies and Clinical Trials
The U.S. Food and Drug Administration (FDA) announced in the Federal Register on April 1, 2011, the availability of a Draft Guidance for Industry titled "Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act" (the "Draft Guidance"). Comments on the Draft Guidance may be submitted at any time.
United States
15 Apr 2011
18
Pennsylvania District Court Prevents Disclosure of Hundreds of Confidential Settlement Agreements
In a scrimmage over the legality of settlement agreements relating to only one drug, the U.S. District Court for the Eastern District of Pennsylvania—in FTC v. Cephalon—provided what may be considered a win-win scenario for much of the pharmaceutical industry and for the Federal Trade Commission (FTC).
United States
4 Apr 2011
19
FDA Removes More Than 500 Unapproved Prescription Cough, Cold And Allergy Drug Products From The U.S. Market
The U.S. Food and Drug Administration (FDA) announced in the Federal Register on March 3, 2011, that it will remove unapproved prescription cough, cold and allergy medications from the market as part of its ongoing Unapproved Drugs Initiative to stop the sale of drugs that do not meet current standards.
United States
20 Mar 2011
20
Fifth Circuit Rules In Favor Of Compounding Pharmacies, In Medical Center Pharmacy v. Holder
On February 25, 2011, in the latest scrimmage between the U.S. Food and Drug Administration (FDA) and compounding pharmacies, the U.S. Court of Appeals for the Fifth Circuit held—in Medical Center Pharmacy v. Holder.
United States
12 Mar 2011
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