Joanne Hawana

Joanne Hawana

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FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more

6/26/2015  /  Counterfeit Drugs , Counterfeiting , Department of Homeland Security (DHS) , Food and Drug Administration (FDA) , Generic Drugs , INTERPOL , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Websites

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

6/24/2015  /  Advertising , CEOs , False Advertising , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Misleading Statements , Off-Label Promotion , Pharmaceutical Industry , Prescription Drugs

FDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018

Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over...more

6/22/2015  /  Food & Drug Regulations , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Manufacturers , Trans Fat

FDA Finally Releases Initial Framework for Food Importation “VQIP”

As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness...more

6/10/2015  /  Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Safety , FSMA , Imports

Will State Action on Biosimilars Thwart Anticipated Savings for Private and Government Health Care Programs?

Government and private health-care program payers have been anxiously awaiting FDA action on biosimilars. Payers anticipate that the ability to substitute and dispense a biosimilar product in lieu of a more expensive...more

6/4/2015  /  Biologics , Biosimilars , Healthcare , Pharmaceutical Industry , Prescription Drugs

FDA Makes More Electronic Submissions Mandatory

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more

5/26/2015  /  Abbreviated New Drug Application (ANDA) , E-Filing , FDASIA , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Prescription Drugs

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more

5/15/2015  /  Biosimilars , Food and Drug Administration (FDA) , New Guidance , Prescription Drugs

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more

5/15/2015  /  DSCSA , Food and Drug Administration (FDA) , Healthcare , Pharmaceutical Industry , Pharmacies , Prescription Drugs , Supply Chain

FDA Finalizes Key Guidance Documents on Biosimilars

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The...more

5/3/2015  /  Biosimilars , BPCIA , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Healthcare , Pharmacies

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more

4/28/2015  /  Biologics , Biosimilars , Food and Drug Administration (FDA) , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

4/17/2015  /  Advertising , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Warning Letters
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