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Rx Drugs

September 21, 2017 | Daily News

A new white paper by the Duke-Margolis Center for Health Policy appears to put to bed a question that has flummoxed FDA and its advisers: whether real-world evidence (RWE) can include randomization.

September 21, 2017 | Daily News

FDA, Centers for Disease Control and Prevention and United States Department of Agriculture will hold their first public meeting in three years on the National Antimicrobial Resistance Monitoring System (NARMS), the agencies announced Tuesday (Sept. 20).

September 21, 2017 | Daily News

Public Citizen sued FDA Thursday (Sept. 21) in an attempt to force the agency to take action on the advocacy group's citizen petition asking FDA to address what the group claims are life-threatening health risks with over-the-counter drugs containing benzocaine, such as infant teething products.

September 20, 2017 | Daily News

CMS is requesting advice for designing demonstrations, including pilots on new Medicare and Medicaid drug payment models, but House Republicans are warning their former colleague HHS Secretary Tom Price about messing with Part B drug reimbursement.

September 20, 2017 | Daily News

Congressional Diabetes Caucus Co-chairs Diana DeGette (D-CO) and Tom Reed (R-NY) wrote to FDA Commissioner Scott Gottlieb Wednesday (Sept. 20) urging the agency to revise guidance on the Biologics Price Competition Innovation and Act (BPCIA)'s “deemed to be a license” provisions, arguing FDA's existing policy discourages market entry for lower price insulin products.

September 20, 2017 | Daily News

FDA is going against congressional intent and potentially running afoul of the law by quietly killing its earlier plans to implement portions of the Drug Quality and Security Act (DQSA), a drug industry attorney tells Inside Health Policy.

September 20, 2017 | Daily News

The CEO of leading compounder, Imprimis Pharmaceuticals, tells Inside Health Policy that despite allegations that it is running afoul of multiple federal laws, FDA is aware of the company's actions and almost all compounders are compounding ingredients that have not been greenlighted by FDA and face no enforcement action.

September 20, 2017 | Daily News

The United States government has once again sided with the biosimilar industry in the latest iteration of litigation surrounding the so-called patent-dance provisions of the Biologics Price Competition and Innovation Act -- arguing in a remanded portion of the highly watched Amgen v. Sandoz Supreme Court case that no additional remedies are available under state law for non-compliance with the patent dance.

September 18, 2017 | Daily News

FDA will release guidance within two months green lighting certain office-use compounding, so long as those 503A pharmacies register as 503B outsourcing facilities, and in exchange these compounders will be subject to “more tailored” manufacturing standards, an agency spokesperson tells Inside Health Policy.

September 15, 2017 | Daily News

Former CMS administrator Andy Slavitt tells Inside Heath Policy that he is skeptical Congress will pass drug-pricing legislation in short order -- though he maintains that such measures could move when Congress needs a payfor.

September 15, 2017 | Daily News

CMS on Wednesday (Sept. 13) sent proposed changes to the Part D and Medicare Advantage programs to the White House Office of Management and Budget for review.

September 15, 2017 | Daily News

The American Academy of Pediatrics applauded FDA's planned effort to cut back abuse of an exemption in the Orphan Drug Act that allows drug developers to avoid the requirement to study drugs for pediatric use.

September 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb said the agency will soon make more health-related data public, including data sets compiled by FDA, adverse event reports, and letters on Risk Evaluation and Mitigation Strategies (REMS).

September 14, 2017 | Daily News

FDA approved Thursday (Sept. 14) the first biosimilar to treat cancer, Amgen's biosimilar to Genentech's Avastin.

September 14, 2017 | Daily News

Lawmakers may need to tweak provisions in the recently released over-the-counter monograph reform discussion draft that give FDA authority to issue administrative orders on packaging requirements for OTC drugs and to award two years of exclusivity to OTC drug manufacturers. FDA and stakeholders pointed to both provisions as issues that require a second look from Congress during the House Energy & Commerce health subcommittee’s Wednesday (Sept. 13) hearing on the bill.

September 13, 2017 | Daily News

A top FTC attorney appeared to temper hopes from the generic drug industry that the FTC would take on alleged anticompetitive consolidation in the purchaser markets, namely among wholesalers, noting that when considering mergers the commission typically views the lowering of prices as positive.

September 12, 2017 | Daily News

Despite strong drug industry opposition, the California Assembly on Monday (Sept. 11) passed a bill to require that drug makers notify purchasers before significantly raising prices and require health plans to report the percentage of premiums spent on drugs.

September 12, 2017 | Daily News

Despite strong drug industry opposition, the California Assembly on Monday (Sept. 11) passed a bill to require that drug makers notify purchasers before significantly raising prices and require health plans to report the percentage of premiums spent on drugs.

September 12, 2017 | Daily News

The House Energy & Commerce Committee will hold a full committee hearing in October to discuss the opioid epidemic.

September 11, 2017 | Daily News

FDA Commissioner Scott Gottlieb said the agency is taking steps to make the clinical trial process smoother and less costly for sponsors, including: embracing seamless trial designs, which abandon the traditional three phases of trials; using master protocols; and relying on advanced computational modeling.

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