Perspectives on Food, Drug, Medical Device & Cosmetic
224 total results. Page 8 of 9.
Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017.
Continuing a trend that is certain to keep growing, three consumer groups recently filed a lawsuit against Sanderson Farms alleging false advertising for their poultry products labeled "100 percent natural."
On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.
In a widely anticipated move, the FDA announced this week that it will extend the July 2018 compliance date for the revision to the Nutrition Facts panel. The revised panel will display calories more prominently on the label, as well as list added sugars.
With organic foods now accounting for over $40 billion in total US food sales, and the accompanying larger scale of organic operations, increased scrutiny of the integrity of the National Organic Program represents a natural progression in the evolution of the program’s history.
This week, Sonny Perdue became the penultimate nominee for President Trump’s cabinet to be confirmed by the Senate.
National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests.
The Food and Drug Administration has just announced that it will hold a Public Meeting on March 9, 2017 to discuss use of the term “healthy” in the labeling of human food products.
Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.
The White House issued an executive order on January 30, 2017 requiring agencies and executive departments to "identify at least two existing regulations to be repealed" whenever they propose or promulgate a new regulation.
Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.
What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved.
On December 9, 2016, the Senate Agriculture Committee filed report language for the National Bioengineered Food Disclosure Law, the legislation signed into law by President Obama in July to amend the Agricultural Marketing Act of 1946.
On December 7, 2016, FDA published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements, and cosmetics.
USDA’s Food Safety Inspection Service (FSIS) recently announced that meat and poultry products may use the Nutrition Facts label recently finalized by FDA earlier this year.
Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.
On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.
A review of FSIS recall data from the past five years indicates that recalls of meat and poultry products due to the presence of foreign matter contamination have grown in number, particularly over the past year.
Earlier this week, the US Food and Drug Administration (FDA) issued revised food safety standards known as the “Manufactured Food Regulatory Program Standards” (MFRPS).
Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.
FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.
The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.
As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.
Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time.
The Beer Institute (BI) announced last week that is was implementing a “Brewer’s Voluntary Disclosure Initiative” intended to encourage its membership to begin disclosing nutritional information about its products on product labeling, packaging and on product websites.