The United States Food and Drug Administration

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
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FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

FDA Issues Two Additional Draft Guidance Documents on Social Media

On June 17, 2014, the US Food and Drug Administration (FDA) released two additional draft guidance documents relating to the pharmaceutical industry's use of social media. One of the guidance documents addresses how...more

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

Proposed Changes to Nutrition Facts Panels Discussed at FDA Public Meeting

On Thursday, June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting in Washington, D.C. to discuss the two proposed rule changes to the Nutrition Facts panels seen on most packaged foods in the U.S....more

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

FDA Warning on Hysterectomy Procedure Raises Awareness of Cancer Risk

A cancer risk surrounding a technologically advanced and minimally invasive surgery for removing the uterus has prompted the Food and Drug Administration to issue a warning discouraging the medical procedure. ...more

Closely Held Corporations Can Be Exempt from ACA Contraception Provisions Based on Religious Objections

The Patient Protection and Affordable Care Act (ACA) requires certain employers to cover women’s preventive health care under their nongrandfathered group health plans at no cost to employees. The U.S. Department of Health...more

Raising “Cane” in Labeling Claims

Class action plaintiffs again allege that the labeling on Chobani’s Greek yogurt violates FDA regulations and misleads consumers, even though a federal court in California dismissed a similar labeling class action earlier...more

FDA Draft Guidance - Best Practices for Developing Drug Trademarks

In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more

FDA Updates to Nutritional Label and Serving Sizes

On June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the proposed changes to the nutrition label and serving sizes. The meeting was attended by interested parties both in Washington,...more

Food and Beverage News and Trends

FDA clarifies its stance on cheese making. On June 13, the FDA issued a clarification stating it “does not have a new policy banning the use of wooden shelves in cheese-making, nor is there any requirement in effect...more

Health Care Update - June 2014 #4

In This Issue: - Hobby Lobby decision further complicates ACA implementation - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

NNI Publishes Progress Review of 2011 EHS Research Strategy

On June 25, 2014, the National Nanotechnology Initiative (NNI) posted Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy, which...more

Markit to Market - June 2014

In This Issue: - FDA Draft Guidance: Best Practices for Developing Drug Trademarks - U.S. Patent and Trademark Office Proposes Fee Reductions - gTLD Sunrise Periods Now Open - Excerpt from U.S. Patent and...more

POM Wonderful Decision: Companies Cannot Rely on FDCA for Protection from False Advertising Liability

The US Supreme Court allows private parties to bring Lanham Act claims challenging product labels that otherwise satisfy the Food, Drug, and Cosmetic Act. In a battle of the beverages, the Supreme Court recently...more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

FDA Issues Draft Guidance Eliminating Regulatory Controls on Medical Device Data Systems, Imaging Storage Devices, and Imaging...

On June 20, 2014, the United States Food and Drug Administration (FDA) issued a draft guidance document announcing that the agency does not intend to enforce the general regulatory controls applicable to medical device data...more

BREAKING: Supreme Court 5-4 Finds in Favor of Hobby Lobby

Burwell v. Hobby Lobby: Regulations issued by the U.S. Department of Health and Human Services under the Affordable Care Act required that employers provide coverage for 20 contraceptive methods approved by the Food and Drug...more

Advertising Law - June 2014 #4

Don’t Forget: FTC Settlement Over Memory Claims - The marketers of the BrainStrong dietary supplement – which claimed to improve adult memory and prevent cognitive decline – reached a settlement with the Federal Trade...more

POM v. Coca-Cola Further Dilutes Consumer Class Action Claims for Deceptive Labeling

The Supreme Court's recent decision in POM Wonderful LLC v. Coca-Cola Company could have redefined the consumer class action landscape with respect to claims for the deceptive labeling of food products. Instead, the decision...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

Supreme Court Opens Door to Food and Beverage Label Challenges Under Lanham Act

The United States Supreme Court paved the way on June 12 for competitors to challenge FDA-regulated food and beverage labels under the Lanham Act. The Court's opinion in POM Wonderful LLC v. The Coca-Cola Co, is the latest...more

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