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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.

The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) characterization studies to establish bioequivalence in abbreviated new drug applications (ANDAs) for topical medications.

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency.

The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. The agency said its new framework is intended to prevent potential shortages of drugs considered especially important on the Union List of Critical Medicines (ULCM).

The U.S. Food and Drug Administration (FDA) is seeking public feedback on whether its scale-up and post-approval changes (SUPAC) guidance documents for the pharmaceutical industry need to be updated and modernized.

The top lawmaker on the Senate Health, Education, Labor, and Pensions (HELP) Committee published a report this week on reforming the US Food and Drug Administration (FDA). The report argues the changes would cut red tape, make the US more attractive to clinical research, and accelerate the approval of medical products.

The generic drug industry told the US Food and Drug Administration (FDA) that it opposes waiving annual facility fees for the first three years for companies that establish manufacturing operations for finished generic drugs or active pharmaceutical ingredients (APIs) in the US during user fee negotiations.

Stakeholders want the US Food and Drug Administration (FDA) to clarify and streamline regulatory requirements for sponsors of nonprescription over-the-counter (OTC) drugs. They also cautioned that the agency should avoid measures that could harm the generic drug industry, which could ultimately raise drug prices.

The US Food and Drug Administration (FDA) has proposed waiving annual facility fees for the first three years for companies that establish manufacturing operations to manufacture finished generic drugs or active pharmaceutical ingredients (APIs) domestically. However, the pharmaceutical industry has opposed this proposal, arguing that there are more effective ways to enhance domestic manufacturing capacity.

Biosimilar industry groups have expressed support for a recent guidance from the US Food and Drug Administration (FDA) that recommends the elimination of comparative efficacy studies (CES) for most biosimilar products and instead would rely on comparative analytical assessments (CAAs) to demonstrate comparability.

The European Medicines Agency (EMA) said it recommended approval of more than a hundred new drugs in 2025, of which about 40% were for new active substances that had not previously been authorized in Europe. The agency notes it's the second-highest number of drug recommendations it has given in the past 15 years.

The European Commission, the European Parliament, and the Council of the European Union have agreed on a significant reform of the EU's pharmaceutical legislation. If the proposed legislation is adopted, it will reportedly simplify the drug regulatory regime within the economic zone, promote innovation, and secure the drug supply chain, according to EU officials.

More than five years after the US Food and Drug Administration (FDA) asked manufacturers to pull drugs with ranitidine off the shelves due to concerns of elevated cancer risk, the agency has approved a reformulated version of the drug. The agency has also asked consumers to take certain steps to reduce the risk of the drug producing carcinogens.

Industry, patient groups, and academics seek more clarity from the US Food and Drug Administration (FDA) regarding its plans to require drug and biologic manufacturers to update their labeling after detecting safety signals. Several industry and research advocacy groups have written to the agency regarding a recent draft guidance that outlines its process for requiring safety labeling changes (SLC), asking for more details on how the agency arrives at its decisions and what information it will disclose publicly.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

A study by US Food and Drug Administration (FDA) officials published in JAMA Internal Medicine earlier this week found that competitive generic therapies (CGTs) approved by the US Food and Drug Administration (FDA) were launched faster than traditional generics. This swift launch enables these products to compete more quickly with brand-name drugs, the authors said.

The US Food and Drug Administration (FDA) recently finalized guidance detailing the criteria it will use to evaluate waiver requests for pH adjusters submitted by sponsors of abbreviated new drug applications (ANDAs). This guidance is applicable to parenteral, ophthalmic, and otic drugs that are Q1 (qualitatively) or Q2 (quantitatively) different from the reference listed drug.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, the longest government shutdown in history ended Wednesday evening when President Donald Trump signed a stopgap spending bill that was narrowly approved by the House earlier that day, enabling FDA to resume some work it paused during the shutdown and begin accepting submissions that require a fee.

Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration's (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector.