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CDER’s Office of Surveillance and Epidemiology (OSE) 2022 Annual Report showed the total number of adverse event (AE) reports rose slightly from 2.23 million in 2021 to 2.34 million, capturing patient adverse reactions along with medication error reports and product quality complaints. Read More
The FDA’s long-awaited draft guidance on decentralized trials (DCT) is finally out and industry experts say that while the guidance has done many things right, recommendations on how sponsors monitor remote locations, such as in patients’ homes, may draw industry pushback. Read More
The FDA has proposed a rule to require sponsors of all new — and already-approved — outpatient prescription drugs and blood products to create a single-page Prescription Medication Information (PMI) sheet explaining how to use the drug, its benefits and its potential risks in plain, easy-to-understand language. Read More
The House Energy and Commerce Committee marked up and advanced a bill last week that would improve cost transparency for pharmacy benefit managers (PBM) by requiring that hospitals provide patients with itemized lists for “shoppable services,” including the amount the hospital has negotiated with third-party payers for such services. Read More
The European Medicines Agency (EMA), along with the regulatory authorities of three member nations, is starting a one-year pilot to test the use of electronic product information (ePI) for human medicines in the EU. Read More
The FDA issued four guidance documents on Thursday covering a variety of topics, including efficacy endpoints for antidiabetic drugs, adjusting for covariates in randomized clinical trials, electronic submission of study data and tissue containment systems used during power morcellation procedures.Read More
A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Read More
India-based drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) has drawn two FDA warning letters in recent weeks over untested glycerin in gastrointestinal products for children, among other serious current good manufacturing practice (cGMP) violations. Read More
The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance. Read More
The International Council on Harmonisation (ICH) has released a draft guideline on good clinical practice (GCP), designed to facilitate acceptance of clinical trial data by ICH member countries and regions. Read More
Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Read More
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More