News Briefs -
FDA Exempts Some Medical Devices from Premarket Review -
FDA closed out the year with the publication of a final order that exempts dozens of Class I and Class II medical devices from 510(k) premarket...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
4/22/2016
/ Abbott Laboratories ,
All Natural ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Investors ,
Medicare Part B ,
Misleading Impressions ,
Natural Products ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Fraud
On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more
4/12/2016
/ Biotechnology ,
Board of Directors ,
Capital Raising ,
Corporate Officers ,
Disgorgement ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Misleading Statements ,
Permanent Injunctions ,
Personal Liability ,
Securities and Exchange Commission (SEC) ,
Securities Fraud