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Filtering on: "topics drugs"

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Regulatory Recon: Former Congressman Waxman Says Drugmakers are Taking Advantage of Orphan Incentives; ANVISA Approves GW's Cannabis-Based Sativex (17 January 2017) By Michael Mezher - Published 17 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

NICE Halts Plans to Charge for Appraisals By Zachary Brennan - Published 16 January 2017

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Reimbursement

Tags: Brexit, UK Life Sciences, ABPI, NICE

Drug Compounding With Bulk Substances: FDA Offers Interim Policies By Zachary Brennan - Published 16 January 2017

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Quality

Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy

Regulatory Recon: Trump Promises 'Insurance for Everybody'; FDA Extends Review of Lilly Rheumatoid Arthritis Drug (16 January 2017) By Michael Mezher - Published 16 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging By Michael Mezher - Published 16 January 2017

The US Food and Drug Administration (FDA) last week finalized its guidance on repackaging drugs by pharmacies and registered outsourcing facilities and also issued a revised draft guidance detailing its policies on mixing, diluting and repackaging certain types of biological products outside of the scope of an approved biologics license application (BLA).

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

Regulatory Recon: Trump Meets With Silicon Valley Insiders for FDA Pick; Lilly Defeats Teva in Alimta Patent Dispute (13 January 2017) By Michael Mezher - Published 13 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

Categories: News, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: RLD, generic drugs, ANDA, ANDA submission

Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: endpoints, clinical trials, clinical guidance, FDA guidance

180-Day Exclusivity for Generics: FDA Releases Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: 180-day exclusivity, generic drugs, FDA guidance

European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017) By Nick Paul Taylor - Published 12 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: regulatory harmonization, ICMRA, Bayer, biologic quality standards

Regulatory Recon: Trump Meets with NIH Contenders; NICE Backs Novartis Kidney Cancer Drug (12 January 2017) By Michael Mezher - Published 12 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Trump Sides With HHS’ Burwell and Democrats on Drug Price Negotiations By Zachary Brennan - Published 11 January 2017

President-elect Donald Trump on Wednesday opened his press conference with an unexpected shot at pharmaceutical companies and their lobbying groups on Capitol Hill, saying, "They’re getting away with murder."

Categories: News, US, Drugs, Government affairs

Tags: Donald Trump, PEOTUS, Burwell, Medicare Part D, drug price negotiations

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

FDA and MHRA Break Down Foreign Inspection Data By Zachary Brennan - Published 11 January 2017

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

Categories: News, Europe, US, FDA, MHRA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: foreign drug inspections, foreign device inspections

Regulatory Recon: Merck Gambles on Early sBLA for Keytruda Combo; FDA Accepts BLA Mylan & Biocon's Proposed Biosimilar Trastuzumab (11 January 2017) By Michael Mezher - Published 11 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs By Michael Mezher - Published 11 January 2017

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

Categories: News, US, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: National Cancer Institute, NCI, NCI Formulary, Oncology

FDA’s Approval of a New Abuse-Deterrent Opioid Raises Questions By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: opioid, opioid abuse, marketing exclusivity, FDA drug approval, abuse-deterrent opioid

Regulatory Recon: Highly-Valued Moderna Hits Safety Problems with Lead Drug; HHS Secretary Calls for Medicare to Negotiate Drug Prices (10 January 2017) By Michael Mezher - Published 10 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017) By Nick Paul Taylor - Published 10 January 2017

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

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: AstraZeneca, Bristol-Myers Squibb, Merck, CDSCO, codeine

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

FDA Issues Labeling Guidance for Aspirin, Acetaminophen By Michael Mezher - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC acetaminophen-containing products.

Categories: News, US, FDA, Over the counter drugs, Labeling, Packaging

Tags: Aspirin, Acetaminophen

FDA, DOJ Investigate Galena Biopharma’s Former Promotions of Fentanyl By Zachary Brennan - Published 09 January 2017

Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015.

Categories: News, US, DOJ, FDA, Advertising and Promotion, Drugs, Regulatory intelligence

Tags: Galena, DOJ, Abstral, fentanyl marketing

Updated: FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics Providers By Zachary Brennan - Published 09 January 2017

The Food and Drug Administration (FDA) on Tuesday will release draft question-and-answer guidance, supplementing another draft from 2014, to help drug wholesale distributors and third-party logistics understand their annual reporting requirements.

Categories: News, US, FDA, Distribution, Drugs, Labeling, Packaging

Tags: DSCSA, wholesale drug distributor, drug logistics, FDA guidance

Regulatory Recon: Takeda Buys Ariad for $5.2 Billion; Merrimack to Sell Oncology Assets to Ipsen (9 January 2017) By Michael Mezher - Published 09 January 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA Releases Q&A on Exposure Limits and Hazardous Compounds By Zachary Brennan - Published 09 January 2017

The European Medicines Agency (EMA) on Monday released for public consultation a new question and answer document focused on the risk-based prevention of cross contamination in pharmaceutical manufacturing and setting health-based exposure limits for risk identification.

Categories: News, Europe, EMA, Drugs, Preclinical

Tags: hazardous drug compounds, EMA guidance, HBELs