Devices
FDA has published a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, clarifying how the agency evaluates real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for
Drugs
FDA has chosen two investigational drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Voucher program, according to internal agency documents reviewed by Reuters. The drugs — a cholesterol treatment and an oncology therapy — could become the 17th and 18th products included in the fast-track
Drugs
A 6/9-6/13 FDA inspection at the 3D Imaging Drug Design and Development drug manufacturing facility in Little Rock, AR, found multiple violations in its production of positron emission tomography (PET) drugs. A 12/4 Warning Letter says specific current good manufacturing practice (CGMP) violations were: * company facilities
Drugs
FDA has extended the review of Aldeyra Therapeutics’ NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye disease treatment by three months. Aldeyra says the agency has set a new user fee review action target date of 3/16/2026 after classifying the company’s
Drugs
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for (1) increasing the enrollment of females in clinical trials and non-interventional studies; (2) analyzing and interpreting sex-specific data; and (3) including sex-specific information in regulatory submissions of
Drugs
President Trump has appointed Yale epidemiologist Harvey Risch to chair the President’s Cancer Panel, a move that is raising alarm among cancer researchers and public health experts because of Risch’s past promotion of unproven Covid-19 treatments and speculation about links between vaccines and cancer, according to Wired.
Drugs
FDA has released the form FDA-483 issued following a 9/9-9/19 inspection at the ProRx outsourcing facility in Exton, PA. The seven inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Biologics
A 3/31-4/6 FDA inspection at the Microvascular Tissue facility in San Diego, CA, determined that the company’s mVASC, derived from hypodermis recovered from donors and marketed for allogenic use, is an unapproved new drug and an unlicensed biological product. A 12/3 Warning Letter says the
FDA Policy/General
FDA commissioner Marty Makary sought to position himself as a supporter of vaccines while defending recent agency actions that have drawn scrutiny, including an internal memo on child deaths following Covid-19 vaccination and changes to hepatitis B vaccine recommendations for infants. In an interview with NPR, Makary said FDA
Biologics
FDA has “no plans” to add a Black Box Warning to Covid vaccines, FDA commissioner Marty Makary said in a Bloomberg TV interview, emphasizing that the agency’s focus is on transparency and updated risk assessments rather than broad changes to vaccine policy. Makary said the FDA’s safety and
Biologics
Vanda Pharmaceuticals has filed a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory skin disease with no broadly effective long-term therapies. The disorder is driven in many cases by mutations in the IL36RN gene that disrupt the body’s natural
Drugs
FDA has proactively awarded Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating relapsed or refractory multiple myeloma, citing strong late-stage clinical trial results. The award brings the total number of products selected under the Commissioner’s National Priority Voucher pilot program to
Drugs
Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis (PPMS) after the drug failed to meet its primary endpoint in a pivotal Phase 3 trial, dealing a setback to the company’s ambitions for the brain-penetrant BTK inhibitor even as regulatory review continues
FDA Policy/General
FDA says it is removing a long-standing barrier to the use of real-world evidence (RWE) in regulatory reviews, signaling a significant shift in how the agency evaluates data submitted in drug and medical device applications. “In new guidance for certain types of medical device submissions, the agency states
FDA Policy/General
FDA has released two final guidances that provide recommendations to help clinical investigators comply with the safety reporting requirements for IND and IDE studies. The first guidance, “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices,” provides recommendations to help investigators identify drug-related serious adverse events that must be
Devices
The Government Accountability Office (GAO) is urging HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how the agency oversees medical device recalls, including lengthy delays in formally closing recalls of high-risk products. In a just-released report, GAO found that FDA
Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentech’s pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, expanding treatment options for patients with advanced disease. The approval covers patients whose tumors are HER2-positive — defined
Drugs
FDA has released updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practices, and adopt more flexible trial designs to ensure clinical studies better reflect the patients who will ultimately use approved medicines. The guidance, Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and
Drugs
A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clinical trials used to secure FDA drug approvals fail to reflect the racial and ethnic makeup of the U.S., and that representation has worsened in recent years. Published in
Drugs
FDA and drug-industry negotiators exchanged early feedback on the agency’s proposed “America First” fee incentives for domestic drug development during an 11/13 Prescription Drug User Fee Act (PDUFA) reauthorization steering committee meeting, according to newly released minutes. The proposal, first outlined by FDA at an 11/6
Drugs
FDA has approved Janssen’s Akeega — a fixed-dose combination of niraparib and abiraterone acetate — with prednisone for adults with metastatic castration-sensitive prostate cancer (mCSPC) harboring deleterious or suspected deleterious BRCA2 mutations. The approval requires use of an FDA-authorized companion diagnostic to confirm BRCA2 status. The decision marks
Biologics
FDA is preparing to add a Boxed Warning — the agency’s most stringent safety alert — to Covid-19 vaccines, according to two people familiar with the deliberations. The potential move marks a dramatic escalation in the Trump administration’s ongoing campaign to scrutinize and restrict use of the vaccines, which