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Consumer Drugs
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ISSN (Print) 1530-1206
Published by Informa plc

[9 journals]

Eye Drop Manufacturers Get Advice On Seeing Quality Clearly In US FDA
Draft Guidance
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  Abstract: Need for guidance shown not only in recalls over past year of OTC eye drops due to bacterial contaminants found... Related Stories
  French Industry Faces €850m In Price Cuts & Curbs On Prescribing
  Bad News For Amylyx As EMA Upholds Rejection Of ALS Drug Albrioza
  EMA Backs Approval Of Santhera’s Agamree, Pfizer’s Elrexfio & Several Other New Drugs
  PubDate: Sat, 14 Oct 2023 13:32:00 GMT
FTC's GOP Seat Nominees Formerly Clerked For Justice Thomas, Led
Conservative Policy Group
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  Abstract: Amid period of 3-0 decisions by commission, President Biden nominates two state solicitor generals for vacant FTC seats, both reserved... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Wed, 05 Jul 2023 22:16:58 GMT
Biden Calls For Expanding Access To Reproductive Health Care, Including
OTC Oral Contraceptives
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  Abstract: President’s “Executive Order on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services” is third on reproductive health care... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Fri, 23 Jun 2023 18:33:16 GMT
First OTC Oral Contraceptive Has Advisory Panel’s Unanimous Support
Despite FDA’s Data Concerns
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  Abstract: FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Wed, 10 May 2023 21:52:23 GMT
US Smoking Cessation Clinical Trials Guidance ‘Does Not Envision’
Flexibility On Indications
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  Abstract: FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Sun, 30 Apr 2023 22:51:34 GMT
With FDA Guidance Urging Innovation, Will Novel Smoking Cessation Products
Surface In US'
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  Abstract: CDER reiterates expectation for multiple trials to demonstrate efficacy for an IND different from approved products, such as route of... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Sun, 30 Apr 2023 20:27:02 GMT
Green Light For First OTC Naloxone In US After FDA Raises Caution Flag
During Advisory Panel
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  Abstract: Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Wed, 29 Mar 2023 23:35:43 GMT
Naloxone Switch NDA Submitted As US FDA Signals Nonprescription Access
Looks Safe, Effective
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  Abstract: Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Tue, 15 Nov 2022 23:56:08 GMT
US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription
Sales
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  Abstract: Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Tue, 15 Nov 2022 22:50:07 GMT
Opioid Emergency Clears Supply Chain Security Impediments To Naloxone
Distribution
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  Abstract: The groups on the front lines of the opioid epidemic may not be physicians or pharmacists or drug wholesalers, but... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Fri, 23 Sep 2022 12:28:28 GMT
After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers
‘Novel Switch’ Pathway
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  Abstract: Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of... Related Stories
  Coronavirus Notebook: UK Approves Comirnaty XBB.1.5, CEPI & Oxford Uni Strike ‘Disease X’ Vaccine Deal
  European HTA Network Rejects Industry Criticism Of Joint Clinical Assessments
  Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
  PubDate: Wed, 29 Jun 2022 10:59:00 GMT
Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval
Process
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  Abstract: The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for...
  PubDate: Wed, 29 Jun 2022 08:33:00 GMT
US FDA's First-Ever Countrywide Import Alert For Drugs Bans
Mexican Hand Sanitizers
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  Abstract: Move reflects agency’s growing frustration over deadly methanol adulteration, puts onus on Mexican manufacturers to prove safety and efficacy.
  PubDate: Fri, 29 Jan 2021 18:46:53 GMT

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