Search Results for

Filtering on: "geography us"

Showing 1 – 25  of 2981

ISO: Identification of Medicinal Products Standards Revised By Zachary Brennan - Published 23 October 2017

The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information.

Categories: News, Canada, Europe, US, ISO, Compliance, Drugs, Government affairs

Tags: IDMP standards

Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 October 2017) By Zachary Brennan - Published 23 October 2017

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

Categories: News, Asia, Europe, US, EC, EMA, FDA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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

FDA Warns Lead-Testing Diagnostics Company By Zachary Brennan - Published 23 October 2017

The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations.

Categories: News, US, CDRH, Due Diligence, Medical Devices, Quality

Tags: lead tests, Magellan Diagnostics, Meridian Bioscience

Will FDA Add Suffixes to Approved Biologics' Names? By Zachary Brennan - Published 20 October 2017

Back in January, the US Food and Drug Administration (FDA) finalized 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

Tags: biosimilars, biosimilar naming

Regulatory Recon: Celgene Abandons Late-Stage Trial in Crohn’s Disease (20 October 2017) By Zachary Brennan - Published 20 October 2017

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

Categories: News, Europe, US, EMA, FDA, NICE

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

FTC Seeks Comments on Competition in Prescription Drug Markets By Zachary Brennan - Published 19 October 2017

Ahead of a November workshop in which FDA Commissioner Scott Gottlieb will give a keynote address, the Federal Trade Commission (FTC) is seeking comments on a variety of questions related to competition issues in the US prescription drug market.

Categories: News, US, FTC, Business and Leadership, Crisis management, Distribution, Drugs, Regulatory intelligence, Regulatory strategy

Tags: FTC on drug prices

Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents By Zachary Brennan - Published 19 October 2017

The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib).

Categories: News, US, CDER, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: FDA guidance, product-specific guidance, generic drug guidance

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming

Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017) By Zachary Brennan - Published 19 October 2017

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

Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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

How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss By Zachary Brennan - Published 18 October 2017

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: News, India, US, MHLW, Government affairs, In vitro diagnostics, Medical Devices, Reimbursement

Tags: stents, knee implants, India price ceilings, medical devices in india

Updated FDA Manual Offers Inside Look at Inspection Protocols By Zachary Brennan - Published 18 October 2017

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

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

Tags: FDA inspections, contamination, sterile environments

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: ICH funding, E9, E11, S5

FDA Officials Offer Advice on Efficient Orphan Drug Development By Michael Mezher - Published 17 October 2017

A group of top US Food and Drug Administration (FDA) officials shared insights on how drugmakers can be more efficient when developing treatments for rare diseases, according to comments on Tuesday at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products

Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System By Zachary Brennan - Published 17 October 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: News, US, Drugs, Reimbursement

Tags: pharmaceutical pricing, Senate HELP committee, PhRMA

Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017) By Zachary Brennan - Published 17 October 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

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

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement By Zachary Brennan - Published 16 October 2017

In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to pay to transfer the patents to a Native American tribe and prolong the launch of Restasis generics.

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

Tags: Restasis, Allergan, Saint Regis Mohawk Tribe

Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities By Michael Mezher - Published 16 October 2017

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

Categories: News, US, FDA, Clinical, Medical Devices

Tags: Patient Engagement, PEAC

EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals By Zachary Brennan - Published 13 October 2017

As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: cancer drug approvals, QoL, survival benefit

Meeting With FDA After a CRL: Draft Guidance on What to Expect By Zachary Brennan - Published 13 October 2017

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CRL, complete response letter, draft guidance

PDUFA VI: FDA Explains User Fee Changes in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

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

Tags: PDUFA VI, prescription drug user fees, draft guidance

FDA Panel Votes Unanimously in Favor of Gene Therapy to Treat Rare Eye Disorder By Zachary Brennan - Published 12 October 2017

Philadelphia-based Spark Therapeutics took its gene therapy before the US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee on Thursday and the panel voted 16 to 0 in favor of approving the subretinal injection, representing a major step forward for adeno-associated virus gene therapies.

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

Tags: Spark Therapeutics, gene therapy, retinal disease, Luxturna

FDA Holds First Patient Engagement Advisory Committee Meeting By Michael Mezher - Published 12 October 2017

The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices.

Categories: News, US, FDA, Clinical, Medical Devices

Tags: Patient Engagement, PEAC, Patient Engagement Advisory Committee, Patient Reported Outcomes, Patient Preference Information

When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

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

Tags: 505(b)(2) application, ANDA, FDA draft guidance

340B: Health System Execs Push Back on Narrowing of Drug Discount Program By Zachary Brennan - Published 11 October 2017

The House Energy & Commerce's subcommittee on Oversight and Investigations on Wednesday discussed the federal 340B drug discount program, which provides participating hospitals and other medical providers deep discounts on outpatient drugs. 

Categories: News, US, Drugs, Government affairs, Reimbursement

Tags: 340B program, drug discounts, pharmaceutical companies