Fact sheet from the Food and Drug Administration which explains the Clinton Administration's plan to strengthen and improve food safety under the Food Safety Initiative.
Industry guide prepared by the Food and Drug Administration regarding regulatory requirements for marketing cosmetics in the United States.
This Alert discusses case law and legislation regarding off-label provisions of the food & drug administration.
By the time fenfluramine and its sister drug, dexfenfluramine were recalled, an estimated 6 million Americans and a.
Drug manufacturers do not have a legal duty to use pharmacogenetics or pharmacogenomics to reduce the risk of idiosyncratic drug-induced liver injury, according to Texas defense attorney Jack E. Urquhart and associates C. Kelvin Adams and Laura E. De Santos, who say the fields are simply too immature to serve as the foundation for a liability claim
Document prepared by the Food and Drug Administration (FDA) which answers frequently asked questions regarding preemption and the FDA's final rule on tobacco.
Industry guide from the Food and Drug Administration regarding cosmetic good manufacturing.
On April 7, 2000, the Health Care Financing Administration (HCFA) published its final regulation (65 FR 18,434 et s.
On December 28 the White House became the latest governmental entity to address the issue of whether on-line pharmacies should be regulated, proposing an initiative that would subject pharmacies selling drug products over the Internet to regulation by the Food and Drug Administration (FDA).
The FTC recently approved the merger of Pfizer Inc. and Pharmacia Corporation. Pfizer is purchasing Pharmacia for an estimated $60 billion solidifying its position as the world's largest pharmaceutical company. Pfizer will control 11 percent of the world's pharmaceutical market, up from 8 percent, with annual revenue estimated to increase to $46 billion from $32 billion.
Publication from the Food and Drug Administration which explains Title II of the Drug Price Competition and Patent Term Restoration Act under which certain patent holders have the opportunity to extend the terms of certain patents.
This article reviews the potential next mass tort in the nutraceuticals market.
Summary prepared by the Food and Drug Administration regarding the rule on children and tobacco which is aimed at regulating commercial speech to ensure that an illegal activity is not promoted.
Guide for consumers from the Food and Drug Administration on how to read cosmetic labels. Also describes how cosmetic labels are regulated.
"Security trumps trade has become a political mantra in the United States " since the terrorist attacks on September 11, 2001. The most serious issue affecting Canada 's international trade performance today is unrestricted access to the U.S. marketplace. The Canadian government has restructured institutions to adjust to this new trade and security nexus.
Publication from the Food and Drug Administration (FDA) which explains the three classes of recalls and discusses FDA's role in the recall process.
This guide provides information about seizures and forfeitures by the U.S. Customs Service.
On August 6, 1999, the Food and Drug Administration (FDA) proposed to amend its current regulations governing the 180-day market exclusivity that is granted to certain generic drug products. This proposed rule represents a significant change to the current landscape of drug exclusivity.
On August 14, 2000, the Food and Drug Administration ("FDA")'s Center for Devices and Radiological Health issued ".
"Security trumps trade has become a political mantra in the United States" since the terrorist attacks on September 11, 2001. The most serious issue affecting Canada's international trade performance today is unrestricted access to the U.S. marketplace. The Canadian government has restructured institutions to adjust to this new trade and security nexus.
Latex gloves used by health care workers and others have allegedly caused respiratory, cardiovascular and skin diso.
The Law Offices of Christopher E. Grell is one of only a handful of law firms in the United States who represents.
This article concerns the newly proposed legislation facing our lawmakers in the U.S. Congress that will directly i.
The United States Patent Laws grant to a patentee the right to prevent others from.
Homeland security is really an amalgam of some 40-plus different federal laws. Many states have their own counterparts. These laws affect plant security, identification of key assets and processes, background checks on new employees, employee access to sensitive areas, cybersecurity, and transportation of products and services.
This article discusses the issue of public safety when using quasi-medical devices without the guidance of a medical professional. This article outlines whether the FDA has jurisdiction over such health and fitness products that are marketed directly to consumers or over the internet.
Question and answer guide for manufacturers engaged in exporting Food and Drug Administration regulated food and cosmetic products to a foreign country.
Publication from the Food and Drug Administration (FDA) which explains the FDA's new food labeling regulations.
Answers to questions regarding the testing of beef products contaminated with E. coli O157:H7 from the Food and Drug Administration. Discusses protocols for testing and actions which should be taken once it has been determined the beef is contaminated.
This article discusses the progress of consumer rights legislation in the wake of the growth of corporate lobbying efforts.
This article discusses the results of a study that researched whether improved rental real-estate management could be induced by police action and whether this would reduce crime.
Employer drug and alcohol abuse prevention and testing programs recently received a boost when the U.S. Supreme Court ruled in Gonzales v. Raich, No. 03-1451 (June 6, 2005), that state laws authorizing the use of marijuana to treat illness do not insulate drug users from federal law making such behavior criminal.
Publication from the Food and Drug Administration which explains the regulation of food coloring under the Federal Food, Drug, and Cosmetic Act of 1938.
You don't need to make this decision on your own. Always consult your physician, particularly your obstetrician, be.
Manufacturing crude methamphetamine has become relatively easy, and more and more people are looking for a fast .
Industry guide prepared by the Food and Drug Administration on consultation procedures regarding foods derived from new plant varieties.
Toxic Shock Syndrome, (hereinafter "TSS"), a serious and often fatal blood disease, has been linked to the use of m.
Publication from the Food and Drug Administration (FDA) on how to report complaints and adverse reactions with products regulated by the FDA.
Guide which lists the information that should be submitted to FDA when requesting that the agency review a specific use of a food contact article to determine whether its components will require regulation as a food additive.
This Drug Enforcement Agency pamphlet challenges the medical use of marijuana arguments and discusses the political and social issues surrounding the use of marijuana.
Guidelines from the Food and Drug Administration on how to submit a request to export to foreign countries products subject to the Federal Food, Drug, and Cosmetic Act and other acts the Food and Drug Administration administers.
Summary from the Food and Drug Administration (FDA) of the Greensboro, North Carolina, Federal District Court's ruling on April 25, 1997 that the FDA has jurisdiction under the Federal Food, Drug, and Cosmetic Act to regulate nicotine-containing cigarettes and smokeless tobacco.
For at least the last 20 years, two counties in Texas had become affectionately known as the number 1 and number 2 litigation hell holes in the nation. The courts in those counties frequently set the nationwide pace for critical pretrial activities in mass tort litigation. Courts in those counties decide everything from who gets deposed and when, to what documents get produced and when, and finally to who gets to see those documents and when.
Synopsis from the Food and Drug Administration for consumers regarding the principal requirements of food law.
Industry guide from the Food and Drug Administration on how to file notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body.
Guide from the Food and Drug Administration which provides assistance to manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic.
Recently, medical evidence concerning popularly prescribed diet pills has raised the possibility that thousands of .
This article discusses some changes in the Fastener Quality Act.
Claims resulting from latex exposure in the workplace continue to crowd the court dockets at epidemic levels.
This newsletter covers a new rule issued by the Food and Drug Administration regarding the Medical Device Amendments Act of 1976 which would not only expose manufacturers to more lawsuits, it would deny consumers access to some life-saving or life-enhancing products.
This bulletin provides information about the potential effects of the Y2K problem on medical devices and the health industry.
Recent court decisions reflect increasing judicial interest in the constitutional protections afforded to speech regarding the safe and effective use of pharmaceutical drugs.
On April 7, 2005, the U.S. Food and Drug Administration (FDA) asked Pfizer, Inc., to remove its Cox-2 inhibitor, BEXTRA, from the market. Pfizer recalled BEXTRA, citing the potential for increased risk of heart attack and stroke. While sound evidence exists that BEXTRA also causes severe forms of skin disorders, including Stevens Johnson Syndrome (SJS) in patients taking the drug, Pfizer denied the recall was based upon these adverse skin conditions.
What is the meaning of "importation"? Are U.S. importers free to deal with all countries when importing prod.
Despite the fact that Federal agencies have not yet been able to reach a consensus on the regulation of latex glov.
Guide from the Food and Drug Administration which explains for small businesses the legal requirements set forth in the current regulation for the labeling of juice products that have not been processed to prevent, reduce, or eliminate harmful bacteria
A. NEGLIGENCE: 1. DUTY: a.Van Horn v. Chambers, 970 S.W.2d 542 (Tex., July 3, 1998): The Court h.
Draft guidance from the Food and Drug Administration regarding rules which effective February 27, 1997 which prohibit retailers from selling cigarettes, loose cigarette tobacco, and smokeless tobacco to anyone under age 18, and require retailers to verify by means of photo identification the age of anyone under age 27 who wishes to purchase these products.
Statement from the Federal Trade Commission (FTC) which provides guidance interpreting the FTC's enforcement policy with respect to the use of nutrient content and health claims in food advertising.
Companies developing pharmaceutical products know the importance of selecting and clearing a trademark early in t.
Analysis for consumers of the New Requirements for Dietary Supplement Labels from the Food and Drug Administration.
Federal agencies have not yet been able to reach a consensus regulation of latex gloves, exposure to which has resu.
Recently, the Food and Drug Administration issued draft guidelines demonstrating how the agency will regulate hospitals that re-use disposable or single use medical devices.
For the past several years, an herbal supplement craze has been sweeping the country. Promises and claims of fast .
Enforcement statistics suggest an increase in violative conduct identified by the Agency in its oversight of clini.
The prescription pharmaceutical industry has matured rapidly with respect to its understanding of the value of trademarks. Ten years ago, it was uncommon to see advertisements for prescription medications. Today, with successes like Viagra® and Claritin®, one can hardly watch television or read a magazine without being exposed to an advertisement for the latest prescription medication. Prescription drug trademarks are important marketing tools that can add great value to a company.
The decision of the U.S. District Court for the District of Columbia in Washington Legal Foundation v. Shalada1 (WL.
In July 1999, the U.S. District Court for the District of Columbia issued the third in a series of decisions in Wa.
Summary from the Food and Drug Administration (FDA) of the Fourth Circuit Court of Appeal's ruling that the FDA lacked the jurisdiction to regulate tobacco products, reversing the April 27, 1997 decision of the U.S. District Court for the Middle District of North Carolina.
Overview of the Food and Drug Administration's seafood regulatory program.
Summary prepared by the Food and Drug Administration of the Dietary Supplement Health and Education Act.
Answers to frequently asked questions from the Office of Orphan Products Development regarding the use and designation of orphan drugs.
Manufacturers should be aware of their responsibilities and requirements under the Safe Medical Devices Act. They m.
The FDA has exercised a rigorous pre-market approval process for medical devices since 1976. Yet not all products liability claims involving medical devices are subject to federal regulatory preemption. This article defines the current boundaries between federal and state laws that affect medical devices.
Summary from the Food and Drug Administration of the procedures the Unlisted States importer must follow when handling food products.
The landscape of laws, regulations and codes governing advertising and marketing is complex and multijurisdictional. This past year has brought about significant change for advertisers and marketers in the following areas.
Publication from the Food and Drug Administration which describes small business food labeling exemptions under 21 CFR 101.9(j)(1).
This article highlights some of the opportunities and pitfalls awaiting health care contractors in dealing with the Department of Defense and Department of Veterans Affairs.
Retailers Guide from the Food and Drug Administration regarding regulations to restrict the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents (21 CFR Part 897).
On March17th the Food and Drug Administration (FDA) issued, amidst great fanfare, a regulation governing labels fo.
When the importance of the matter requires a focused presence at agency headquarters, and in-house or trade associa.
Shortly after the June 2000 issue of Update went to print, the Health Care Financing Administration (HCFA) announce.
Manufacturers of medical devices suffered a major setback recently when a federal appellate court held that "premar.
Publication from the Food and Drug Administration which explains the regulation of food additives under the Federal Food, Drug, and Cosmetic Act of 1938.
Backgrounder from the Food and Drug Administration which describes the Modernization Act of 1997.
Publication from the Food and Drug Administration (FDA) which provides a description for consumers of the FDA authorized health claims and some specifics on their use.
Guide from the Food and Drug Administration which outlines new federal regulations concerning children and Tobacco.