In a draft guidance document, the US Food and Drug Administration stated that in certain cases, it will allow probiotic products to use colony-forming units to quantify live microbial ingredients on the Supplement Facts...more
The federal bill was signed into law on May 30 by the president, and will present new opportunities and challenges to clinical trial sponsors and healthcare entities....more
The US Food and Drug Administration’s new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will affect device development strategies, including where to conduct such trials....more
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and, if working with IVD...more
Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....more
The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases.
On April 14, the health committees for both the US Senate and the US House of Representatives released a...more
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products.
This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more
Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more
No more sugar coating—the Rules impose new label requirements, and manufacturers will incur additional costs.
The US Food and Drug Administration (FDA or the Agency) has announced the issuance of two new final rules: one...more
The enforcement date will likely begin in May 2017.
The US Food and Drug Administration (FDA) issued its final guidance on April 29 on Menu Labeling (Final Guidance). Importantly, the FDA intends to begin enforcing the...more
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.
In recent years, issues involving the integrity of and controls around manufacturing data...more
FDA agrees to allow truthful and non-misleading off-label promotion.
On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
8/11/2015
/ Amarin ,
Caronia ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs
FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine.
On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain...more
The guidance calls for 2014 reporting by April 1, 2015.
When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...more
The Supreme Court holds that competitors may bring Lanham Act claims challenging food and beverage labels that are regulated by the FDA....more
The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for ALA.
On April 28,...more
The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register...more
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more
Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising.
Recent Federal Trade Commission (FTC) enforcement activities—including a...more
FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance.
On January 14, the U.S. Food and Drug Administration (FDA or...more
Proposed requirements dictate a substantial upgrade of the current regulatory standard of care.
On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority.
On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more