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Filtering on: "topics packaging"

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Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements By Zachary Brennan - Published 10 October 2017

Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers.

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

Tags: child-resistant packaging, Boehringer Ingelheim, FDA draft guidance

FDA Offers Draft Guidance to Further Secure Drug Supply Chain By Zachary Brennan - Published 21 August 2017

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Biologics and biotechnology, Distribution, Drugs, Labeling, Packaging, Regulatory strategy

Tags: DSCSA, track and trace, FDA guidance, drug supply chain

Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance By Zachary Brennan - Published 08 August 2017

With an increased demand for the repackaging of solid oral dosage form drugs into unit-dose containers, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.

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

Tags: expiration date, FDA draft guidance, repackaging

FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings By Michael Mezher - Published 19 July 2017

The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023.

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

Tags: DSCSA, Supply Chain

FDA Delays UDI Requirements for Low-Risk Devices By Michael Mezher - Published 05 June 2017

The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices.

Categories: News, US, FDA, Labeling, Medical Devices, Packaging

Tags: Unique Device Identifier, UDI

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

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

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

Danish Regulator Suspends Parallel Importer's GMP Certificate By Michael Mezher - Published 06 January 2017

The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month.

Categories: News, Europe, Compliance, Distribution, Drugs, Packaging

Tags: Danish Medicines Agency, Europharma DK

European Regulatory Roundup: EMA Releases Draft Guidance on Using Pictograms on Packaging (1 December 2016) By Nick Paul Taylor - Published 01 December 2016

The European Medicines Agency (EMA) has posted draft guidance on the use of approved pictograms on veterinary medicinal product packaging. EMA has drafted the document to create a harmonized set of pictograms marketing authorization holders (MAHs) can use to communicate effectively in the limited space available on product packaging.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Labeling, Packaging

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal By Zachary Brennan - Published 30 August 2016

After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the agency stopped short of finalizing several provisions that commenters took issue with.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Labeling, Packaging, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NDCs, drug establishment registration, FDA drug lists, FDA rules, drug regulations

FDA Pushes Back Enforcement of UDI Rule Provisions By Zachary Brennan - Published 29 August 2016

The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.

Categories: News, US, FDA, Labeling, Medical Devices, Packaging, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: UDI Rule, unique device identifier, NDC number, NHRIC number, medical device label

10 Disruptive Technologies and the Regulatory Implications By Zachary Brousseau - Published 17 August 2016

The healthcare products sector has seen the introduction and development of a number of disruptive technologies in recent years. The future of healthcare lies in groundbreaking tech like 3D printing and personalized medicine. But these new innovations also bring regulatory challenges. This article examines 10 disruptive technologies regulatory professionals should be tracking.

Categories: HTML, Articles, Under RAPS, RAPS, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Compliance, Ethics, Labeling, Manufacturing, Medical Devices, Packaging

Tags: disruptive technology, regulation, Regulatory Convergence, #2016RAPS

ISO IDMP: Another Compliance Project or a new way of Conducting Business? By Rune Bergendorff - Published 19 April 2016

This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently.

Categories: Features, Europe, EC, EMA, Drugs, Labeling, Packaging

Tags: IDMP, ISO, Identification of Medicinal Products, Regulatory Information Management

Senate Committee Advances Five More Bills as Part of Medical Innovation Package By Zachary Brennan - Published 06 April 2016

The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Combination products, Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Packaging, Postmarket surveillance, Product withdrawl and retirement, Reimbursement

Tags: Senate companion bills to Cures, 21st Century Cures, Senate Medical Innovation, Senate HELP

FDA Offers Final Proprietary Naming Guidance to Minimize Medication Errors By Zachary Brennan - Published 06 April 2016

The final guidance from the US Food and Drug Administration is part of a host of proprietary name evaluation measures from the reauthorization of the Prescription Drug User Fee Act and aims to help reduce medication errors.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Labeling, Packaging, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical proprietary name, FDA drug naming guidance

New FDA Draft Guidance for Orthopedic Device Developers By Zachary Brennan - Published 11 February 2016

The US Food and Drug Administration (FDA) on Thursday released new draft guidance to help Class II and III orthopedic device developers understand what type of information to include in their submissions for devices using ultrahigh molecular weight polyethylene (UHMWPE) material.

Categories: News, US, FDA, Clinical, Due Diligence, Medical Devices, Packaging, Project management, Research and development

Tags: FDA draft guidance, orthopedic device guidance, UHMWPE

EU Regulation Requires New Safety Features on Drug Packaging by 2019 By Michael Mezher - Published 09 February 2016

A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019.

Categories: News, Europe, EC, EMA, Prescription drugs, Labeling, Packaging

Tags: Falsified Medicines Directive, Unique Identifier, Anti-tampering device

How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains By Zachary Brennan - Published 15 January 2016

The US Food and Drug Administration (FDA) is looking to shed more light on how two or more medical devices packaged together, in what the agency calls a “convenience kit,” would need to comply with unique device identifier (UDI) labeling requirements.

Categories: News, US, FDA, Labeling, Medical Devices, Packaging

Tags: UDI rule, unique device identifier, packaged medical devices, device regulations

Proposed Rule Would Revise Regulations on Fixed-Combination Drugs By Zachary Brennan - Published 22 December 2015

The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and co-packaged drugs, as well as to combinations of over-the-counter active ingredients.

Categories: Biologics and biotechnology, Business Skills, Clinical, Combination products, Compliance, Drugs, Ethics, Government affairs, Labeling, Orphan products, Packaging, Preclinical, Project management, Regulatory strategy, Submission and registration

Tags: fixed-combination drugs, FDA rulemaking, proposed FDA rule, OTC drug monographs, nonprescription drug combinations

FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen By Zachary Brennan - Published 16 November 2015

The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours.

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

Tags: Acetaminophen, Tylenol, liver warning, liver damage, OTC, FDA labeling guidance

FDA Releases Draft Guidance on Injectable Drug Dose Labeling By Michael Mezher - Published 21 October 2015

Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling, Medical Devices, Packaging

Tags: Injectable drugs, single-use, multiple-use, single-dose, single-patient-use

FDA to Approve ANDAs on the Basis of Draft Labeling By Zachary Brennan - Published 05 October 2015

The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.

Categories: News, US, FDA, Generic drugs, Due Diligence, Government affairs, Labeling, Packaging, Regulatory intelligence, Regulatory strategy

Tags: ANDA, draft labeling, drug labels, FDA guidance, FPL, OGD

MHRA Wants Input on Single-Use Device Re-Manufacture Guidance By Michael Mezher - Published 21 July 2015

The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices.

Categories: News, Europe, EC, MHRA, Government affairs, Labeling, Manufacturing, Medical Devices, Packaging, Quality

Tags: Single-use device, Reprocessing, Re-manufacturing

Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada By Ryan Thompson, Vadim Lysenko, Mukesh Kumar, Giri Venkiteela, Lewis Lau - Published 05 June 2015

An overview of compliance activities applicable for drugs and biologics in the US and Canada, as well as useful tools to strengthen quality compliance programs.

Categories: Features, Canada, US, FDA, Health Canada, Compliance, Drugs, Manufacturing, Packaging, Quality