Articles
Bring in OTC Drugs Lawyers in Washington, D.C
by Whiteshark Media White Shark MediaDefending a person
in a criminal trial or representing a person through a divorce are far from the
only tasks a lawyer can handle. In fact, many attorneys are in practice areas
that have little to do with a courtroom at all! It should come to no surprise that
you cannot just put whatever you want on a product label and sell it. But how
do you know what to say, how to market a product, how to keep track of any
potential side effects, and where you’re allowed to sell it? There are
attorneys who are experts in these legal issues. You’ll need a special lawyer
like this when your company is going through the process of getting any type of
over the counter (OTC) drug ready to go to market. Hiring OTC
Drugs Lawyers in Washington, D.C can help with:
#1 Labeling and Advertising Review. Is your new drug ready to be
sold in stores? Attorneys provide regulatory counseling to help your company
determine whether your brand new product can be marketed as an OTC drug under
the OTC monograph, a homeopathic drug, or require a New Drug Application. A
firm will also assist you with labeling and advertising review to help ensure
compliance with applicable federal regulations.
#2 Facility Registration and Product Listing. All drug manufacturers, processors, packers, repackers, labelers, and
relabelers who offer drugs for sale or distribution in the U.S. are required to
register their drug establishments with the FDA. Every drug establishment
registered with FDA must submit a list of every drug they have in commercial
distribution to obtain NDC (National Drug Code) numbers. You will need OTC Drug
Attorneys in Washington, D.C to register your drug establishment and list your
drug products.
#3 Adverse Event Reporting. For
any type of OTC drug, record keeping is a big deal. It is not just a
suggestion! Drug firms are required to report to the FDA certain adverse events
associated with their products and maintain reports of adverse events. A team
of lawyers will be there to assist you in the process of identifying and
reporting adverse events, training monitoring staff on the process, and
conducting audits to assess compliance
#4 Export Certificates. Does
your new OTC drug need an Export Certificate to Foreign Governments, Certificate
of Exportability, or Certificate of a Pharmaceutical Product? You may not be
sure whether to use Form 3613a or 3613b, but a specialized lawyer does! This
attorney can help you apply for the right export certificate. Be sure to go
with a well-established firm who has the experience to make the process simple
and straightforward. An attorney will be able to eliminate confusion on forms
and what attachments to include.
Getting your new OTC drug to market is the only way to make money off of it. Before you can, you must bring in a team of lawyers to make sure everything is in place to sell it and keep on the market legally.
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Created on Feb 20th 2020 23:30. Viewed 386 times.
