In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons -
On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
2/10/2020
/ Anti-Competitive ,
Biologics ,
Biosimilars ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Labeling ,
Misleading Statements ,
Prescription Drugs ,
Public Comment
Implications for 510(k) Submissions -
On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more
The Updated Code Includes Several New Topics and Additional Guidelines on Existing Topics -
The Advanced Medical Technology Association (AdvaMed) published in late December 2018 an updated version of its widely-adopted...more
FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process -
Last week FDA released two statements announcing plans and...more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors -
On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
6/21/2018
/ Final Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Labeling ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Required Communications ,
Safe Harbors
In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more
On January 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more
1/23/2017
/ 21st Century Cures Act ,
Draft Guidance ,
FDAMA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCEI ,
Investigational New Drug Application (IND) ,
Manufacturers ,
Material Dissemination ,
Payor Contracts ,
Safe Harbors ,
Section 502
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more