The FDA clarified the agency’s interpretations of what is meant by “suspect” and “illegitimate” products in the Drug Supply Chain Security Act (DSCSA) in a final guidance released Thursday. Source:…
U.S. District Judge Matthew Kacsmaryk, the Texas federal judge who could outlaw the abortion pill, mifepristone, said he will render a decision on the case “as soon as possible.” Source:…
On Wednesday, the Biden administration released a list of 27 drugs and biologics whose prices are rising faster than the rate of the inflation, and thus whose manufacturers will owe…
Sponsors developing long-acting local postoperative anesthetics should consider including novel, clinically meaningful endpoints in their trial design, the FDA has said in new draft guidance. Source: Drug Industry Daily
The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance released Wednesday. Source: Drug Industry Daily
The FDA dinged Dunagin Pharmaceuticals’ Rogers, Ark., drug manufacturing facility for its water system, its drug manufacturing and equipment cleaning processes, and for other deficiencies observed during an Aug. 29…
The FDA dinged generics maker Cipla’s quality unit for several lapses, including failing to properly investigate batch discrepancies or the impact of power outages on drug product, during a Feb.…
The FDA rapped German pharmaceutical company B. Braun Medical for failing to thoroughly review unexplained batch discrepancies, a quality control unit that lacks the authority over drug products, failure to…
The FDA and the Federal Trade Commission (FTC) have launched a campaign against false or misleading information about biosimilars that “may constitute unfair or deceptive practices” leading to decreased confidence…
Genentech has filed a complaint against Biogen seeking patent royalties from a manufacturing process Biogen allegedly used to produce its multiple sclerosis (MS) drug Tysabri (natalizumab). Source: Drug Industry Daily