AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on enforcement letters and three guidance documents issued by the...more
So far this Fall, the Food and Drug Administration (FDA) has issued four guidance documents regarding the product identifier and verification systems requirements of the Drug Supply Chain Security Act (DSCSA). ...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
The Food and Drug Administration issued two Warning Letters recently to pharmaceutical manufacturers where lack of corporate oversight was an issue. These Warning Letters reaffirm that senior management cannot delegate or...more
In its 1990 hit, “Enjoy The Silence,” Depeche Mode sings, “Words are very unnecessary, they can only do harm.” The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter...more
On June 21, 2018, FDA issued new guidance related to the Prescription Drug User Fee Act. The document, titled Guidance for Industry: Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological...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
FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the...more
Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...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
Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...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
They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...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
8/18/2017
/ Cosmetics ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
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
Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of...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
5/22/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Domain Names ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more
More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently...more
The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more
In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an...more
So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...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
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 Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pay assistance voucher that failed to include risk...more
The Food and Drug Administration announced recently that it intends to re-evaluate its policies on opioid medications, designed “at reversing the epidemic, while still providing patients in pain access to effective relief.”...more