Page 2 - Us Fda

Drug compounders sue FDA over removal of Wegovy, Ozempic from shortage list

The lawsuit claims the FDA's finding that there was no longer a shortage of the drugs' active ingredient semaglutide was arbitrary and capricious

FDA to rehire probationary medical device staffers fired only days earlier

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been rescinded effective immediately, according to messages viewed by The Associated Press. Three FDA staffers impacted by the decisions spoke with the AP on condition of anonymity because they planned to continue working for the agency and weren't authorised to discuss its internal procedures. The reversal is the latest example of President Donald Trump and billionaire Elon Musk's chaotic approach to cost-cutting, which has resulted in several agencies firing, and then scrambling to rehire, employees responsible for nuclear weapons, national parks and other government services. The FDA reinstatements followed pushback by lobbyists for the medical device

USFDA pulls up Jagsonpal Pharma for manufacturing lapses at API plant

The US health regulator has pulled up Jagsonpal Pharmaceuticals for significant manufacturing lapses at its Rajasthan-based active pharmaceutical ingredients (APIs) plant. In a warning letter issued to the company's Managing Director Manish Gupta, the US Food and Drug Administration (USFDA) noted that the correspondence summarizes significant deviations from Current Good Manufacturing Practice for APIs. The US health regulator stated that it inspected the company's Bhiwadi- based plant in Rajasthan on March 20, March 27, and April 3, 2024. "This warning letter summarises significant deviations from Current Good Manufacturing Practice (CGMP) for APIs. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated," the USFDA stated in the warning letter. A warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product ca

FDA staff reviewing Musk's Neuralink among the employees fired by DOGE

The cuts included about 20 people in the FDA's office of neurological and physical medicine devices, several of whom worked on Neuralink

Trump admin fires FDA employees in food safety and medical devices

The Trump administration's effort to slash the size of the federal workforce reached the Food and Drug Administration this weekend, as recently hired employees who review the safety of food ingredients, medical devices and other products were fired. Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of anonymity because they were not authorised to speak publicly. The total number of positions eliminated was not clear Sunday, but the firings appeared to focus on employees in the agency's centres for food, medical devices and tobacco products which includes oversight of electronic cigarettes. It was not clear whether FDA employees who review drugs were exempted from the layoffs. On Friday, the US Department of Health and Human Services announced plans to fire 5,200 probationary employees across its agencies, which include the National Institutes o

US to ban cancer-linked Red Dye No 3 in cereal, candy, other foods

The move comes more than 30 years since the Food and Drug Administration prohibited the use of Red No. 3 in cosmetics after studies found tumors linked to the dye in lab rats

Lupin receives US FDA tentative approval for Ivacaftor Oral Granules

These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral Granules

Lupin gets clearance from USFDA for its Pithampur manufacturing facility

Lupin, headquartered in Mumbai, India, is a global pharmaceutical player with products distributed in over 100 markets

FDA proposes new testing guidelines to ensure asbestos-free cosmetics

Cosmetic companies would have to take extra steps to ensure that any products containing talc are free of asbestos under a new proposed federal rule. The proposal from the Food and Drug Administration on Thursday and mandated by Congress is intended to reassure consumers about the safety of makeup, baby powder and other personal care products. It follows years of lawsuits against Johnson & Johnson and other companies alleging links between talc-based baby powder and cancer. Despite the lawsuits, research has found mixed evidence of a potential link between cancer and talc, although the possibility has been recognised for decades because of how it is mined. Talc is a mineral used to absorb moisture or improve the texture, feel and colour of cosmetics. It is mined from underground deposits that are sometimes located near the toxic mineral asbestos. The risk of cross contamination has long been recognised by cosmetic companies. But recent FDA-sponsored testing hasn't uncovered any ..

Eli Lilly's weight-loss, diabetes drug shortage is resolved, says US FDA

The finding effectively bars widespread sales of cheaper copies of the drugs that many patients use, but the FDA said it would not take any action against the compounding pharmacies

Granules India share tanks 10% after USFDA's 'OAI' tag for Gagillapur Unit

The fall in Granules India share price came after the company announced that United States Food and Drug Administration (USFDA) has classified the inspection of Gagillapur unit as OAI

Marty Makary seen as leading candidate for Donald Trump's FDA pick

Makary, a pancreatic surgeon at Johns Hopkins Medicine, is a health researcher whose latest book focuses on questioning medical orthodoxy on topics from peanut allergies to antibiotics

Dozens fall sick, 1 dead after eating carrots contaminated with E coli

An outbreak of E coli has infected dozens of people who ate bagged organic carrots, and one person died from the infection. Altogether, 39 people were infected and 15 hospitalised in 18 states after eating organic whole and baby carrots sold by Grimmway Farms, the federal Centers for Disease Control and Prevention said on Sunday. Grimmway Farms, based in Bakersfiled, California, has recalled the carrots, which included whole and baby organic carrots sold in bags under multiple brand names. The carrots are no longer in stores but the CDC is warning consumers to not eat recalled bag carrots and to check their refrigerators or freezers and throw away any carrots that fit the description. Most of the infected people live in New York, Minnesota and Washington, followed by California and Oregon, although infections have been reported in states throughout the country, according to the CDC. There have been several E coli outbreaks in recent months. In October, more than 100 McDonald's ...

Dr Reddy's, FDC recall generic medications in US over manufacturing issues

Dr Reddy's Laboratories and FDC Ltd are recalling generic medications in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report by Food and Drug Administration (USFDA), the US-based subsidiary of Dr Reddy's Laboratories is recalling multiple strengths of Morphine Sulfate extended-release tablets in the US. The medication is used to relieve severe and persistent pain. As per the USFDA, Princeton-based Dr Reddy's Laboratories Inc is recalling 2,040 bottles of 15 mg Morphine Sulfate extended-release tablets due to "Failed Impurities/Degradation Specification". The drugmaker is also recalling another 532 100-count bottles of the medication in 30 mg strength for the same reason, USFDA stated. Dr Reddy's initiated the Class II nationwide recall on October 22 this year. USFDA said Mumbai-headquartred FDC Ltd is recalling 1,55,232 bottles of Timolol Maleate ophthalmic solution in the US market. The company is recalling the .

Glenmark arm recalls two products in US due to manufacturing issues

Drug firm Glenmark is recalling two products in the US due to manufacturing issues, according to the US Food and Drug Administration. New Jersey-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharmaceuticals, is recalling 45,504 bottles of Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray. The company is recalling the affected lot due to "defective delivery system", the US Food and Drug Administration (USFDA) said in its latest enforcement report. "The dip tube is clogged causing the spray not to work," it added. Glenmark Pharmaceuticals Inc, USA, initiated the nationwide (US) Class II recall on September 24 this year. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The US health regulator said the drug firm is also ...

US FDA grants fast track status to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is a once-a-day, β-lactam enhancer used for outpatient parenteral antimicrobial therapy

US FDA approves Bristol Myers' Squibb drug for treating schizophrenia

Bristol Myers obtained the drug Cobenfy, also known as KarXT, through its $14 billion takeover of Karuna Therapeutics last year

USFDA cites manufacturing lapses at Zydus Lifesciences' Gujarat plant

The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat-based plant. In a warning letter to company's Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted that the drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district. The USFDA said it inspected the manufacturing facility from April 15 to 23, 2024. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," it added. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated." A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. Elaborating on the manufacturing issues at the facility, USFDA noted: "Your firm failed to thorough

USFDA approves injectable version of Roche's multiple sclerosis therapy

The therapy is already approved as an infusion or IV therapy for multiple sclerosis, which is given twice a year, under the brand name Ocrevus

US FDA expands J&J's psoriasis drug Tremfya for inflammatory bowel disease

Drugmakers such as AbbVie, Eli Lilly and J&J are hustling for a share in an already-crowded, multi-billion market for treatments for inflammatory bowel diseases