Search Results for Zachary Brennan

Showing 1 – 25  of 598

Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA By Zachary Brennan - Published 24 August 2016

The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval for a new strength of a drug.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Quality, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse-to-receive an ANDA, ANDA submission, generic drug submission

PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals By Zachary Brennan - Published 24 August 2016

More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO are pleased with the performance goals outlined by and for the agency from 2018 to 2022.

Categories: News, US, FDA, Business and Leadership, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PhRMA, BIO, PDUFA VI, Prescription Drug User Fee Act

FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies.

Categories: News, US, FDA, Clinical, Drugs, Due Diligence, Medical Devices, Preclinical

Tags: GLP regulations, nonclinical studies, quality inspections, FDA proposed rules

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

FDA Finalizes Two Medical Device Guidelines By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform benefit-risk determinations.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: FDA guidance, medical device guidance, benefit-risk determinations of devices

Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen By Zachary Brennan - Published 22 August 2016

Sen. Amy Klobuchar (D-MN) on Saturday called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Categories: News, US, FDA, FTC, Business and Leadership, Crisis management, Drugs, Government affairs, Medical Devices, Quality

Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders

PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations By Zachary Brennan - Published 22 August 2016

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the user fee program from fiscal years 2018 through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Manufacturing, Quality

Tags: AstraZeneca, PDUFA VI, PDUFA reauthorization, Prescription Drug User Fee Act

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection By Zachary Brennan - Published 19 August 2016

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHRA, TGA, Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing

Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance By Zachary Brennan - Published 19 August 2016

Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets.

Categories: News, US, FDA, Clinical, Compliance, Drugs, Manufacturing, Quality

Tags: chewable tablets, chewable drugs, pharmaceutical comments on FDA guidance, FDA draft guidance

Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches By Zachary Brennan - Published 18 August 2016

Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance that aims to improve the way adhesion data is treated for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches.

Categories: News, US, FDA, Clinical, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Perrigo, Mylan, AstraZeneca, ANDAs for topical patches

FDA Reiterates Concerns on Citizen Petitions Delaying Drug Approvals By Zachary Brennan - Published 18 August 2016

Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions.

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

Tags: citizen petitions, 505(q) petitions, drug approval delays

Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? By Zachary Brennan - Published 17 August 2016

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process

European Commission Offers Guidance on Standalone Software as a Medical Device or IVD By Zachary Brennan - Published 17 August 2016

The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither.

Categories: News, Europe, EC, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: standalone software as a medical device, European Commission guidance

UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges By Zachary Brennan - Published 16 August 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges.

Categories: News, Europe, MHRA, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Roche, insulin pumps, leaking insulin pumps, patients with diabetes, MHRA alerts

FDA to Reclassify Pharmaceutical Co-Crystals By Zachary Brennan - Published 16 August 2016

As part of an effort to clarify and help advance the development of pharmaceutical co-crystals, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance providing information on the appropriate classification of co-crystal solid-state forms, the data that should be submitted to support the classification and the regulatory implications of such a classification.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical co-crystals, salts, polymorphs, FDA guidance

Cancer Immunotherapies: EMA to Hold November Workshop By Zachary Brennan - Published 16 August 2016

The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

Categories: News, Europe, US, EMA, FDA, Business and Leadership, Clinical, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: CAR T, CAR T-cell therapies, immuno-oncology, immunotherapy, EMA workshop on immunotherapies

FDA Offers First Major Update to ‘Orange Book’ Website By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.”

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Orange Book, list of generic drugs from FDA, FDA list of drugs

3D Medical Device Printing: Industry Seeks More Clarity From FDA By Zachary Brennan - Published 15 August 2016

Medical device manufacturers are looking to coax the US Food and Drug Administration (FDA) into providing more clarity on its guidance on 3D printing, according to comments released last Friday.

Categories: News, US, FDA, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: 3D printing of medical devices, 3D devices, additive manufacturing

PDUFA VI: Highlights on What to Expect By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development.

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

Tags: PDUFA, PDUFA VI, real-world evidence, Sentinel, model-informed drug development

FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors By Zachary Brennan - Published 12 August 2016

The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs, Product withdrawl and retirement, Regulatory intelligence

Tags: Bial, Biotrial, France Phase 1 study, clinical trials, FAAH inhibitors

Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority By Zachary Brennan - Published 12 August 2016

A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement, Quality

Tags: China drug manufacturing, Indian APIs, statement of noncompliance, warning letter

FDA Corrects Statutory Error on Informal Hearings Linked to Banned Devices By Zachary Brennan - Published 11 August 2016

The US Food and Drug Administration (FDA) announced it is amending its regulations to correctly reference the statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a banned device.

Categories: News, US, CDRH, Government affairs, Medical Devices, Submission and registration

Tags: device bans, FDA hearings

Data Integrity: New Draft Guidance and Q&A By Zachary Brennan - Published 11 August 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EMA, FDA, Active pharmaceutical ingredients, Business Skills, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: PIC/S, data integrity of medicines during manufacturing, pharmaceutical manufacturing, GMP drug manufacturing

Regulatory Explainer: Everything You Need to Know About Biosimilars By Zachary Brennan - Published 10 August 2016

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.

Categories: News, Africa, Asia, Europe, US, CDSCO, EMA, FDA, FTC, Health Canada, MHRA, Biologics and biotechnology, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: biosimilars, BPCIA, patent dance, biologics, biosimilar savings

Australia Outlines Major Drug Label Changes By Zachary Brennan - Published 09 August 2016

Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find.

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Drugs, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Australia drug labels, drug label, drug labeling changes, dispensing label