Search Results for controlled substances

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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

Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016) By Nick Paul Taylor - Published 13 September 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Crisis management, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Pakistan controlled substances, CFDA on devices, TGA committees

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

Canada Proposes New Drug Enforcement Measures, Including Scheduling By Michael Mezher - Published 11 June 2015

Canada's Minister of Health Rona Ambrose has just announced a series of amendments to the country's Controlled Drugs and Substances Act (CDSA) intended to curb illegal drug manufacturing and use.

Categories: News, Health Canada, Distribution, Drugs, Government affairs

Tags: Controlled substances, inspections, tamper-resistant packaging

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 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

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

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

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

FDA: Stop Manufacturing Unapproved Oxycodone Products By Alexander Gaffney - Published 06 July 2012

Categories: FDA

Tags: Unapproved Drugs Initiative, Painkillers, Controlled Substances Act, oxycodone, Unapproved, Opioids, Latest News

FDA Looks to Reassess Hydrocodone Products By Alexander Gaffney - Published 08 June 2012

Categories: FDA

Tags: Controlled Substances Act, CSA, Hydrocodone, Benefit, DEA, Abuse, Meeting, Latest News, risk