Search Results for Zachary Brennan

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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

FDA Further Explains Delay on LDT Guidance By Zachary Brennan - Published 13 January 2017

Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: lab-developed tests, LDTs, FDA on lab tests

FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017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

US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft 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

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

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

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA 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

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 Offers Final Guidance on CGMP Requirements for Combo Products By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013.

Categories: News, US, FDA, Combination products, Regulatory intelligence, Regulatory strategy

Tags: CGMP, combo products, FDA guidance

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

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

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

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

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

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

Regulatory Recon: Big Ruling Against Sanofi and Regeneron; Obama on Repealing Obamacare (6 January 2017) By Zachary Brennan - Published 06 January 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, EC, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

Mammogram Record Retention: FDA Offers Advice By Zachary Brennan - Published 05 January 2017

Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law).

Categories: News, US, CDRH, Crisis management, Medical Devices, Quality, Regulatory intelligence

Tags: mammogram, FDA and mammography, MQSA

New FDA Drug Approvals: Breaking Down the Numbers By Zachary Brennan - Published 04 January 2017

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: new drug approvals, pharmaceutical approvals, FDA approval

Bipartisan House Bill Seeks to Repeal Medical Device Tax By Zachary Brennan - Published 04 January 2017

Rep. Erik Paulsen (R-MN) and a group of more than 220 bipartisan representatives on Tuesday introduced a bill that would permanently repeal the 2.3% tax on medical device companies under the Affordable Care Act (ACA).

Categories: News, US, Government affairs, Medical Devices

Tags: device tax, medical device legislation, Paulsen, Trump

CDRH Speeds Release of Device Recall Information By Zachary Brennan - Published 03 January 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

Categories: News, US, CDRH, Compliance, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: device recalls, FDA recalls, recall coordinators