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The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use RWE in drug development. Read More
Merck is suing the federal government over the landmark $740 billion Inflation Reduction Act (IRA), questioning the constitutionality of the nearly year-old law designed to lower drug costs. Read More
The FDA is seeking public comment from clinical trial sponsors, sites, investigators and other interested parties on a long-awaited revision of the International Council on Harmonisation’s (ICH) good clinical practice (GCP) guideline, ICH E6. Read More
Compliance with current good manufacturing practice (CGMP) has always been a top enforcement priority for the FDA. And lately, the agency has been taking a tougher stance on one particular CGMP area — process validation. Read More
The use of FDA’s checklist-like cover letter attachments for controlled correspondence and generic drug submissions are voluntary, the agency emphasized in a final guidance released Monday. Read More
A new FDA pilot program to quickly advance gene therapies for rare diseases will use several elements of the Operation Warp Speed medical product development program for COVID-19 products, said CBER Director Peter Marks at the FDA Regulatory Education for Industry (REdI) Annual Conference on Monday. Read More
The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential and request feedback from agency officials on device submissions under the Q-Submission program. Read More
The U.S. Supreme Court on Thursday sent back to a lower court two cases involving a pair of supermarkets accused of overcharging the federal government for prescription drugs in violation of the False Claims Act. Read More
Expanding on the clinical development of migraine drugs, the FDA has published a new draft guidance on development of drugs to prevent migraine to complement its current guidance on developing drugs to treat migraine. Read More
Face-to-face FDA meetings may have a hybrid component beginning June 12, focusing on “having only core participants with a primary speaking role in person while others join virtually” to avoid overcrowding of conference rooms as FDA staff return to on-site work. Read More
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