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Filtering on: "topics drugs prescription drugs"

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EU Court of Justice Denies EMA Appeal to Release Documents on Two Medicines By Zachary Brennan - Published 15 March 2017

The Court of Justice of the EU earlier this month delivered a blow to transparency efforts at the European Medicines Agency (EMA), dismissing two appeals by the regulator.

Categories: News, Europe, EMA, Clinical, Prescription drugs, Government affairs

Tags: PTC Therapeutics, Translarna, Court of Justice of the European Union

May Deadline for FDA's eCTD Transition Approaches By Zachary Brousseau - Published 13 February 2017

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to FDA all New Drug Applications, Biologics License Application and Abbreviated New Drug Applications using the electronic Common Technical Document (eCTD).

Categories: HTML, Articles, Under RAPS, RAPS, Compliance, Generic drugs, Prescription drugs, Submission and registration

Tags: eCTD, electronic Common Technical Document, Submissions

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

FDA Finalizes Guidance on Labeling By Michael Mezher - Published 02 December 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Labeling

Tags: Clinical pharmacology

Drug Marketing on Twitter: FDA to Study Space-Limited Communications By Michael Mezher - Published 07 November 2016

The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: Social media, Twitter, Google

Capsule Supplier Changes: FDA Offers an Updated Policy By Michael Mezher - Published 15 August 2016

Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Manufacturing

Tags: Prior Approval Supplement, Gelatin Capsules, Supplier Change

New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities By Michael Mezher - Published 03 August 2016

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities.

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Manufacturing

Tags: Compounding, Compounded drugs, Outsourcing Facility, Draft Guidance

FDA Unveils User Fee Rates for FY 2017 By Michael Mezher - Published 01 August 2016

In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Medical Devices

Tags: User Fees, PDUFA, BsUFA, MDUFA, GDUFA, FY2017

FDA to Restrict Compounders from Making Copies of Commercially Available Drugs By Zachary Brennan - Published 07 July 2016

The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Over the counter drugs, Prescription drugs, Manufacturing, Quality

Tags: drug compounding, FDA guidance on compounding

What's Happening Down Under? The Australian Regulatory Scene in 2016 By Clive Simon, PhD, MBA - Published 13 June 2016

This article discusses the current regulatory framework for drugs and medical devices in Australia, compares differences in regulatory processes between Australia, the US and the EU and predicts future developments and challenges for industry and regulators.

Categories: Features, Oceania, TGA, Biologics and biotechnology, Cosmetics, Over the counter drugs, Prescription drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products

New Bill Would Speed FDA Review of OTC Contraceptives By Michael Mezher - Published 10 May 2016

A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women.

Categories: News, US, FDA, Over the counter drugs, Prescription drugs, Submission and registration

Tags: Contraceptive mandate, Affordable Care Act, Rep. Mia Love (R-UT), Guttmacher Institute

Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors By Michael Mezher - Published 11 April 2016

The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug's container closure system to minimize the risk of medication errors.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs

Tags: Medication errors

FDA Advisory Committee Calendar By Tarius - Published 15 March 2017

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees

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

Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling By Michael Mezher - Published 27 January 2016

Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Prescription drugs, Government affairs

Tags: Hydrocodone, Opioid epidemic, Schedule II, DEA, Drug Enforcement Agency

FDA Promotional Enforcement Actions Hit Record Low in 2015 By Michael Mezher - Published 19 January 2016

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter

Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs By Michael Mezher - Published 05 January 2016

Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Prescription drugs, Submission and registration

Tags: Abbreviated New Drug Application, ANDA, Compounding, Daraprim, Isuprel

Researchers Call to Modernize Bioequivalence Standards By Michael Mezher - Published 14 December 2015

A group of researchers are calling on the US Food and Drug Administration (FDA) to update generic drug regulations, warning that "outdated" bioequivalence standards threaten patient safety.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Prescription drugs, Manufacturing, Submission and registration

Tags: Bioequivalence

FDA Warns Cancer Center Over Unsanitary Conditions By Michael Mezher - Published 11 November 2015

The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs.

Categories: News, US, FDA, Compliance, Prescription drugs, Manufacturing

Tags: Form 483, Warning Letter, Johnson Memorial Cancer Center, ISO 7, ISO 5, HEPA Filters

GPhA: Congress Needs to Work With FDA to Increase Generic Competition By Zachary Brennan - Published 03 November 2015

The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday.

Categories: News, US, FDA, Compliance, Distribution, Generic drugs, Prescription drugs, Government affairs, Manufacturing, Quality, Regulatory intelligence

Tags: generic drugs, GPhA, ANDAs, Generic Drug User Fee Amendments of 2012, user fees, Turing Pharmaceuticals

Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors By Betsy Kurian, PharmD, Moulakshi Roychowdhury, PharmD, JD - Published 09 October 2015

This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies.

Categories: Features, US, FDA, Advertising and Promotion, Compliance, Prescription drugs, Government affairs

Tags: Office of Prescription Drug Promotion, OPDP, Office of Inspector General, (OIG), Untitled letters, Warning letters

FDA Releases Final Guidance on Integrated Summary of Effectiveness By Zachary Brennan - Published 07 October 2015

More than seven years since unveiling the draft document, the US Food and Drug Administration (FDA) on Wednesday finalized its guidance on how an Integrated Summary of Effectiveness (ISE) should be prepared for new drug applications (NDAs) and biologics license applications (BLAs).

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ISE guidance, BLA, NDA, drug effectiveness, FDA guidance

TGA Weighs Rescheduling Codeine Following Safety Review By Michael Mezher - Published 01 October 2015

Codeine-containing medicines may soon be available by prescription only in Australia, following a review and public consultation by the Therapeutic Goods Administration (TGA).

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Over the counter drugs, Prescription drugs, Government affairs

Tags: Poisons Standard, SUSMP, codeine

Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions By Zachary Brennan - Published 30 September 2015

The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Government affairs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: drug compounding, fungal meningitis, Pharmacy Compounding Advisory Committee, quinacrine hydrochloride

FDA Raises Fee Rate for FY16 Tropical Disease Priority Reviews By Zachary Brennan - Published 11 September 2015

The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016.

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

Tags: Priority Review voucher, FDA, tropical disease priority review, malaria, dengue, PDUFA