FDA Panel Rejects Pfizer's Bid for Booster Shots for 16 and Over FDA Panel Rejects Pfizer's Bid for Booster Shots for 16 and Over
Pfizer's application for a third dose of its mRNA COVID-19 vaccine was rejected for those 16 and over, but the panel may still consider boosters for older adults.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 17, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Alert Source Type: news

Coronavirus (COVID-19) Update: September 17, 2021
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 17, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New and Revised Draft Q & As on Biosimilar Development and the BPCI Act (Revision 3)
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2). ” The question and answer (Q&A) format is intended to inform prospective applicants and facili (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 17, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA ® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor
September 17, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1b/2 NORSE (NCT03473743) study evaluating BALVERSA® (erdafitinib) in combination with cetrelimab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, compared to BALVERSA® monotherapy in patients with locally advanced or metastatic urothelial carcinoma (mUC) with fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations who are ineligible for cisplatin, a current standard of care treatment for mUC. The results were highlighted in an oral present...
Source: Johnson and Johnson - September 17, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX ® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 17, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Analysis Chills the Rush to Approve Boosters FDA Analysis Chills the Rush to Approve Boosters
An FDA report released this week has added doubt to the outcome of an advisory committee meeting on Friday to consider a third booster dose for the Pfizer COVID vaccines.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 17, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

csDMARDs Could Add to TNF Inhibitors' Benefits in SpA csDMARDs Could Add to TNF Inhibitors' Benefits in SpA
EuroSpA Research Collaboration data hint at better retention and remission rates with csDMARD-TNFi cotherapy vs TNFi alone in spondyloarthritis.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 16, 2021 Category: Drugs & Pharmacology Tags: Rheumatology News Source Type: news

FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
FDA revised the  EUA for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in patients who are at high risk for progression to severe COVID-19, including hospitalization or death. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

RPS calls for free flu jabs for pharmacists
RPS is calling on the NHS to offer free flu jabs for all pharmacists in England and Wales following reports that pharmacy teams across primary care, including locum staff, would not be given access to (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 16, 2021 Category: Drugs & Pharmacology Source Type: news

Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry
In October 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Met (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
Oncology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cannabidiol Found No Better Than Placebo for Hand Arthritis Pain Cannabidiol Found No Better Than Placebo for Hand Arthritis Pain
Patients with hand osteoarthritis or psoriatic arthritis who used cannabidiol as an add-on analgesic had results similar to those of placebo.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 16, 2021 Category: Drugs & Pharmacology Tags: Rheumatology News Source Type: news

Access to emergency contraception in pharmacies
BBC3 online recently reported the cases of two women who were unable to access emergency contraception from their local pharmacy. Responding to the piece, RPS President Professor Claire Anderson said: (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 16, 2021 Category: Drugs & Pharmacology Source Type: news

RPS signs letter opposing Vectura takeover news
RPS President Claire Anderson has signed a letter written to Jo Churchill, Minister for Prevention, Public Health and Primary Care, from Asthma UK and the British Lung Foundation to express deep conce (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 16, 2021 Category: Drugs & Pharmacology Source Type: news

US Seniors' Pandemic Care Worst Among Wealthy Nations: Survey US Seniors' Pandemic Care Worst Among Wealthy Nations: Survey
Older adults in the US also report pandemic-related economic difficulties at a rate of up to six times that of other countries.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 15, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

BlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment
To protect public health and safety, the FDA provides guidance to drug manufacturers on staying cyber secure. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pediatric Review Committee (PeRC)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Class 2 Medicines Recall: SANTEN Oy IKERVIS 1 mg/mL eye drops, emulsion
SANTEN Oy (trading as Santen UK Limited) are recalling two batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. F (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - September 15, 2021 Category: Drugs & Pharmacology Source Type: news

HCV Viremic Allografts in Solid Organ Transplantation HCV Viremic Allografts in Solid Organ Transplantation
Given the success of DAA's in treating HCV, might solid organ transplants from HCV+ allografts be a feasible way to expand the pool of available organs?Alimentary Pharmacology & Therapeutics (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - September 15, 2021 Category: Intensive Care Tags: Gastroenterology Journal Article Source Type: news

Nurse Staffing CEO Resigns After Supporting Antimask Group Nurse Staffing CEO Resigns After Supporting Antimask Group
An editorial said the CEO supported an antimask effort started by his 19-year-old son at the same time he profited off COVID-19's spread with rising demand for traveling nurses.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - September 15, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC
Delta-8 THC products are not approved by the FDA and may put you at risk. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Brilliant Enterprises LLC - 609523 - 07/20/2021
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

McDaniel Water, LLC - 616186 - 09/07/2021
Unapproved New Drugs/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Promotion
FDA Drug Info Rounds pharmacists discuss the many elements surrounding the marketing and advertising of a prescription drug product. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Name Review
FDA Drug Info Rounds pharmacists discuss FDA's responsibility for reviewing and approving new product names. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Communicating Benefit and Risk Information
FDA Drug Info Rounds pharmacists talk about the benefit risk balance, and how health care professionals may approach this topic with their patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Electronic Orange Book
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Electronic Orange Book
The Orange Book has long been a reliable resource for information about FDA-approved drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Managing Drug Shortages
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Traveling with Prescription Medications
FDA Drug Info Rounds pharmacists discuss key points pharmacists should counsel their patients on prior to travel. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Info Rounds Video: Expanded Access
FDA Drug Info Rounds pharmacists discuss expanded access to investigational drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

USP Salt Policy (December 2014)
FDA Drug Info Rounds pharmacists discuss the application of the United States Pharmacopeia ’s Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations (USP Salt Policy) by FDA’s Center for Drug Evaluation and Research. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Disposal of Unused Medicines
What do you do with medications that have not been used or are out of date? (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Disposal of Unused Medicines
What do you do with medications that have not been used or are out of date? (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: REMS
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Risk Evaluation and Mitigation Strategies (REMS) Drug Info Rounds Video
REMS are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: NDC Directory
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

NDC Directory (March 2015)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: FAERS
FAERS (April 2015) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FAERS (April 2015)
FAERS is the database that houses reports submitted to FDA on adverse events and medication errors.   (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Medication Adherence
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Antibiotic Resistance (November 2015)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Antibiotic Resistance (November 2015)
Antibiotic resistance is a growing public health concern worldwide. FDA Drug Info Rounds pharmacists discuss how the nation ’s pharmacists can encourage the appropriate use of antibiotics. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Breakthrough Therapy (December 2015)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Breakthrough Therapy (December 2015)
The goal of breakthrough therapy designation is to get certain promising drugs developed and to market as quickly and safely as possible so they can be available to treat the patients who need them. FDA Drug Info Rounds pharmacists discuss the Breakthrough Therapy designation process. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Extortion Scam (September 2016)
FDA Drug Info Rounds pharmacists discuss some simple steps to take if a potential victim receives an extortion call from FDA impersonators. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Emergency Preparedness – Keeping Medications Safe (Feb 2016)
Emergency preparedness should include plans for keeping medications safe. FDA Drug Info Rounds pharmacists discuss the importance of being prepared for emergency situations and discuss the resources that pharmacists can rely on when advising their patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Transcript: Extortion Scam (September 2016)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi ® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination
Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi ® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results. Oral products heavily (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

S12 nonclinical biodistribution considerations for gene therapy products
ICH - Safety (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news