Search Results for DEA

Showing 1 – 25  of 31

FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances By Zachary Brennan - Published 10 January 2017

The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances.

Categories: News, US, FDA, WHO, Drugs, Government affairs, Product withdrawl and retirement

Tags: cannabis, marijuana, controlled substances, DEA

Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling By Michael Mezher - Published 27 January 2016

Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Prescription drugs, Government affairs

Tags: Hydrocodone, Opioid epidemic, Schedule II, DEA, Drug Enforcement Agency

New Law Redefines When Controlled Substances are Officially Approved By Zachary Brennan - Published 30 November 2015

Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: DEA, FDA approval, controlled substances, opioids

Senate Committee Advances Bill Redefining When a Drug is Officially Approved By Zachary Brennan - Published 01 October 2015

A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday.

Categories: News, US, DOJ, FDA, Drugs, Due Diligence, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Controlled Substances Act, DEA, FDA, drug approval, Improving Regulatory Transparency for New Medical Therapies Act

DEA to Allow Huge Increase in Marijuana Production to Meet Research Demands By Alexander Gaffney, RAC - Published 16 June 2015

The US Drug Enforcement Administration (DEA) has proposed a massive increase in the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced.

Categories: News, US, Manufacturing, Research and development

Tags: DEA, Marijuana, Cannabidiol, Marihuana

Government Report Slams DEA for Oversight of Drug Production Quota System By Alexander Gaffney, RAC - Published 07 May 2015

Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found.

Categories: News, US, CDER, Drugs, Manufacturing

Tags: DEA, Drug Shortage, Drug Shortages, APQ, Quota, GAO, GAO Report

DEA to Increase Marijuana Production Quota to Meet Demand of Medical Researchers By Alexander Gaffney, RAC - Published 07 April 2015

The US Drug Enforcement Administration (DEA) is proposing to more than triple the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced.

Categories: News, US, Research and development

Tags: Medical Marijuana, Cannabidiol, DEA, Drug Enforcement Administration, Aggregate Production Quota

House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved' By Alexander Gaffney, RAC - Published 17 March 2015

The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: DEA, Legislation, House, Congress, Improving Regulatory Transparency for New Medical Therapies Act, Drug Approval, CSA, Controlled Substances Act, Scheduling, Drug Enforcement Administration

DEA Scheduling Reform Bill Moves Forward in House By Alexander Gaffney, RAC - Published 13 February 2015

The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly.

Categories: News, US, CDER, Drugs

Tags: DEA, Drug Enforcement Administration, Improving Regulatory Transparency for New Medical Therapies Act, House, Legislation, Bill

DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals By Alexander Gaffney, RAC - Published 21 January 2015

The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA).

Categories: News, US, Drugs, Submission and registration

Tags: DEA, Drug Enforcement Administration, CSA, Controlled Substances Act, Legislation, House, Improving Regulatory Transparency for New Medical Therapies Act, Bill

Anabolic Steroid Regulation Bill Awaits President's Signature By Alexander Gaffney, RAC - Published 15 December 2014

New legislation set to be signed into law by US President Barack Obama would ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products.

Categories: News, US, Drugs, Labeling, Nutritional and dietary supplements, Submission and registration

Tags: Legislation, Bill, Congress, Anabolic Steroid, Designer Anabolic Steroid Control Act, (DASCA), DEA

After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process By Alexander Gaffney, RAC - Published 22 September 2014

For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA), the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA subjects new pharmaceutical products to the CSA scheduling process more predictable and less onerous.

Categories: News, US, FDA, Drugs, Submission and registration

Tags: DEA, Drug Enforcement Administration, Scheduling, Legislation, Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act, Improving Regulatory Transparency for New Medical Therapies Act

DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases By Alexander Gaffney, RAC - Published 05 September 2014

US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA), establishing the quantities of the drugs which may be produced in 2015.

Categories: News, US, Prescription drugs, Manufacturing

Tags: DEA, Drug Production Quotas, Drug Diversion, Drug Quotas, CSA, Controlled Substances Act, Painkillers, Schedule I, Schedule II, List I

Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle By Alexander Gaffney, RAC - Published 27 August 2014

The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug.

Categories: News, US, Prescription drugs, Submission and registration

Tags: Merck, Suvorecant, Belsomra, DEA, Schedule IV, CSA, Controlled Substances Act

DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers By Alexander Gaffney, RAC - Published 21 August 2014

In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law.

Categories: News, US, Distribution, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: DEA, Hydrocodone, Schedule II, Schedule III, Final Rule, Rescheduling, Hydrocodone Combination Products

Bill Aims to Speed up Regulatory Process for Abuse-Prone Drugs By Alexander Gaffney, RAC - Published 27 March 2014

Categories: US

Tags: Scheduling, Controlled Substances Act, CSA, Legislation, House, DEA, Latest News, Bill, pharmaceutical, drug

Attempt to Strengthen Restrictions on Hydrocodone Products Clears Second-to-Last Hurdle By Alexander Gaffney, RAC - Published 26 February 2014

Categories: US, FDA

Tags: Controlled Substances Act, CSA, Hydrocodone, DEA

Will Merck's Suvorexant Avoid DEA's Regulatory 'Black Hole' That Snared Arena's Belviq? By Alexander Gaffney, RAC - Published 14 February 2014

Categories: US, FDA

Tags: Merck, DEA

Congress Presses DEA to Open up on Regulatory 'Black Hole' By Alexander Gaffney, RF News Editor - Published 17 June 2013

Categories: US, FDA

Tags: Letter, DEA, Congress

After Nearly a Year in Regulatory 'Black Hole,' Arena Gets DEA's Approval for Weight Loss Pill Belviq By Alexander Gaffney, RF News Editor - Published 07 May 2013

Categories: US

Tags: CSA, DEA

Civil Rights Group Argues for Protection of Prescription Databases By Alexander Gaffney, RF News Editor - Published 29 January 2013

Categories: FDA

Tags: DEA, database

DEA's Regulatory Agenda Affects Pharma Supply Chain, Distribution and Disposal Regulations By Alexander Gaffney, RF News Editor - Published 08 January 2013

Categories: Distribution

Tags: MEA, Methamphetamine, Controlled Substances Act, CSA, disposal, Supply Chain, DEA, pharmaceutical, industry, drug

DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight By Alexander Gaffney, RF News Editor - Published 18 October 2012

Tags: Schedule I, Ecstasy, MDMA, Methylone, Batch Salts, DEA, Latest News

Legislators, Regulators to Enhance Regulation of Anabolic Steroids By Alexander Gaffney - Published 01 August 2012

Tags: Anabolic Steroid, Steroid, CSA, Legislation, DEA, Latest News, Senate, Bill

DEA to Increase Supply of ADHD, Opioid Ingredients in Light of Shortages By Alexander Gaffney - Published 06 July 2012

Tags: Quota System, ADHD, DEA, Opioids, Latest News, Drug Shortages